Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01371981
First received: June 10, 2011
Last updated: October 22, 2014
Last verified: October 2014
  Purpose

This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib and sorafenib tosylate together with combination chemotherapy may be an effective treatment for acute myeloid leukemia.


Condition Intervention Phase
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Childhood Acute Erythroleukemia (M6)
Childhood Acute Megakaryocytic Leukemia (M7)
Childhood Acute Monoblastic Leukemia (M5a)
Childhood Acute Monocytic Leukemia (M5b)
Childhood Acute Myeloblastic Leukemia With Maturation (M2)
Childhood Acute Myeloblastic Leukemia Without Maturation (M1)
Childhood Acute Myelomonocytic Leukemia (M4)
Untreated Adult Acute Myeloid Leukemia
Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Drug: asparaginase
Drug: daunorubicin hydrochloride
Drug: mitoxantrone hydrochloride
Drug: sorafenib tosylate
Drug: cytarabine
Drug: etoposide
Drug: bortezomib
Other: pharmacological study
Other: laboratory biomarker analysis
Other: questionnaire administration
Other: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial for Patients With De Novo AML Using Bortezomib and Sorafenib ( NSC# 681239, NSC# 724772) for Patients With High Allelic Ratio FLT3/ITD

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • EFS [ Time Frame: From the time on study to induction failure, relapse or death, up to 11 years ] [ Designated as safety issue: No ]
    The Kaplan-Meier method will be used to estimate EFS.


Secondary Outcome Measures:
  • OS [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]
    The Kaplan-Meier method will be used to estimate OS.

  • Remission rate after 1 course of therapy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Remission rate after 2 courses of therapy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients dying in each course of therapy [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]
  • Course duration [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]
  • Length of hospitalization [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]
    Descriptive statistics will be used to summarize length of hospitalization time.

  • Time to blood count recovery [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]
    Cumulative incidence estimates that account for competing events will be used to estimate time to count recovery.

  • Relapse rate assessed by bone marrow analysis for leukemic blasts [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]
    Cumulative incidence estimates that account for competing events will be used to estimate relapse rate.

  • Incidence of treatment-related mortality [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]
    Cumulative incidence estimates that account for competing events will be used to estimate treatment-related mortality.

  • Proportion of patients experiencing grade 3 or higher non-hematologic toxicities and infections assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) [ Time Frame: Up to 11 years ] [ Designated as safety issue: Yes ]
    The proportion of patients experiencing grade 3 or higher non-hematologic toxicities and infections will be estimated.

  • Proportion of high risk children without HR FLT3/ITD+ converting from positive MRD at end of Induction I to negative MRD at the end of Induction II [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]
    The proportion of high risk children without HR FLT3/ITD+ converting from positive MRD at end of Induction I to negative MRD at the end of Induction II will be estimated as well as the corresponding confidence interval. In addition, this proportion will be compared with the proportion for high risk children without HR FLT3/ITD+ treated on AAML03P1 and AAML0531.

  • Parent-reported questionnaire scores [ Time Frame: At 4 months following start of SCT or intensification II of chemotherapy ] [ Designated as safety issue: No ]
    Questionnaires include the Generic Core Scale, Acute Cancer Module, and Multidimensional Fatigue Module summary and dimension scores of HRQOL and Pediatric Inventory for Parents (PIP). Mean values and their 95% confidence intervals (CI) will be presented.

  • Change in parent-reported outcomes over time in recipients of SCT or chemotherapy [ Time Frame: Baseline to up to 11 years ] [ Designated as safety issue: No ]
    Summary measures at each time point as well as the overall trajectory over time in HRQOL and PIP will be described. A mixed linear regression model with repeated measures incorporating covariates as appropriate will be performed.

  • Bortezomib pharmacokinetic plasma concentration-time profiles [ Time Frame: Day 8 of induction II ] [ Designated as safety issue: No ]
    Analyzed using descriptive statistics and will be graphically displayed by age group. PK data will be analyzed using methods such as nonlinear mixed effects modeling to estimate bortezomib clearance (Cl) and volume of distribution (Vd) with associated 95% confidence intervals in each age group (2-11 years and 12-16 years of age).

  • Systemic exposure of sorafenib tosylate and N-oxide metabolite for each course of induction and intensification (CL, Vd, time to maximum concentration [Tmax]½, area under curve [AUC]) [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]
    Descriptive statistics will be used to summarize the systemic exposure of sorafenib tosylate and N-oxide metabolite for each course of induction and intensification (CL, Vd, Tmax½, AUC). If sufficient data is available, comparison to steady state pharmacokinetic data from ADVL0413 will be performed using Wilcoxon sign rank test. For plasma inhibitory assay (PIA)-PK correlations, a random effects linear regression model will be used to describe the relationship between PIA and PK levels for each of the trough plasma samples collected for each patient.

  • Shortening fraction/ejection fraction percentages and change over time [ Time Frame: Baseline to up to 11 years ] [ Designated as safety issue: No ]
    Analyzed by repeated measures analysis of variance accounting for dexrazoxane exposure and other clinically relevant covariates, including age, gender, body mass index, risk group, and treatment arm.

  • Serum concentrations of GVHD biomarkers [ Time Frame: Up to day 28 after SCT ] [ Designated as safety issue: No ]
    Logistic regression modeling will be used to assign individual weights to each individual biomarker and clinical variable to maximize sensitivity and specificity of a mathematical algorithm for the prediction of grade 2-4 GVHD occurring on or before day 56 post-SCT. It will be tested whether algorithms using the day 7, 14, or 28 biomarker panel, or a combination of the biomarker panels at these different time points are most useful for the prediction of GVHD. The different algorithms will be compared on the basis of maximal specificity and sensitivity using the Akaike information criterion.


Estimated Enrollment: 1250
Study Start Date: June 2011
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Induction I, Arm A
Patients receive cytarabine IT on day 1 and ADE chemotherapy comprising cytarabine IV over 1-30 minutes on days 1-10; daunorubicin hydrochloride IV over 1-15 minutes on days 1, 3, and 5; and etoposide IV over 1-2 hours on days 1-5.
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: cytarabine
Given IT or IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Induction I, Arm B
Patients receive cytarabine IT and ADE chemotherapy as in Induction I, Arm A. Patients also receive bortezomib IV on days 1, 4, and 8.
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: cytarabine
Given IT or IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Drug: bortezomib
Given IV
Other Names:
  • LDP 341
  • MLN341
  • VELCADE
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Induction I, Arm C
Patients receive cytarabine IT and ADE chemotherapy as in Induction I, Arm A and sorafenib tosylate PO on days 11-28.
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: sorafenib tosylate
Given PO
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN
Drug: cytarabine
Given IT or IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Induction II, Arm A (LR patients)
Patients receive cytarabine IT and ADE chemotherapy as in Induction I Arm A.
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: cytarabine
Given IT or IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Induction II, Arm A (HR patients)
Patients receive cytarabine IT on day 1 and MA chemotherapy comprising high-dose cytarabine IV over 1-3 hours on days 1-4, and mitoxantrone IV over 15-30 minutes on days 3-6.
Drug: mitoxantrone hydrochloride
Given IV
Other Names:
  • CL 232315
  • DHAD
  • DHAQ
Drug: cytarabine
Given IT or IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Induction II, Arm B (LR patients)
Patients receive cytarabine IT, ADE chemotherapy, and bortezomib as in Induction I Arm B.
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: cytarabine
Given IT or IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Drug: bortezomib
Given IV
Other Names:
  • LDP 341
  • MLN341
  • VELCADE
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Induction II, Arm B (HR patients)
Patients receive MA chemotherapy as in Induction II, Arm A (HR patients) and bortezomib IV on days 1, 4, and 8.
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: mitoxantrone hydrochloride
Given IV
Other Names:
  • CL 232315
  • DHAD
  • DHAQ
Drug: cytarabine
Given IT or IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Drug: bortezomib
Given IV
Other Names:
  • LDP 341
  • MLN341
  • VELCADE
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Induction II, Arm C

Patients receive cytarabine IT on day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes on days 1, 3, and 5, etoposide IV over 1-2 hours on days 1-5, and sorafenib tosylate PO on days 1-28.

Maintenance: Patients receive sorafenib tosylate PO starting on day 40-80 after completion of intensification II or SCT for one year.

Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: sorafenib tosylate
Given PO
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN
Drug: cytarabine
Given IT or IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Intensification I, Arm A
Patients receive cytarabine IT on day 1 and AE chemotherapy comprising high-dose cytarabine IV over 1-3 hours, and etoposide IV over 1-2 hours on days 1-5.
Drug: cytarabine
Given IT or IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Intensification I, Arm B
Patients receive cytarabine IT and AE chemotherapy in Intensification II, Arm A, and bortezomib IV on days 1, 4, and 8.
Drug: cytarabine
Given IT or IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Drug: bortezomib
Given IV
Other Names:
  • LDP 341
  • MLN341
  • VELCADE
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Intensification I, Arm C
Patients receive cytarabine IT and AE chemotherapy in Intensification II, Arm A, and sorafenib tosylate PO on daily on days 1-28.
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: sorafenib tosylate
Given PO
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN
Drug: cytarabine
Given IT or IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Intensification II, Arm A (LR)
Patients receive cytarabine IT on day 1 and MA chemotherapy as in Induction II, Arm A (HR patients).
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: cytarabine
Given IT or IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Intensification II, Arm B (LR)
Patients receive cytarabine IT on day 1, MA chemotherapy as in Induction II, Arm A (HR patients), and bortezomib IV on days 1, 4, and 8.
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: cytarabine
Given IT or IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Drug: bortezomib
Given IV
Other Names:
  • LDP 341
  • MLN341
  • VELCADE
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Intensification II, Arms A and B
Patients receive high-dose cytarabine IV over 3 hours on days 1, 2, 8, and 9 and asparaginase IM on days 2 and 9.
Drug: asparaginase
Given IM
Other Names:
  • ASNase
  • Colaspase
  • Crasnitin
  • Elspar
  • L-ASP
Drug: cytarabine
Given IT or IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Intensification II, Arm C
Patients receive cytarabine IT on day 1, MA chemotherapy as in Induction II, Arm A (HR patients), and sorafenib tosylate PO on days 1-28.
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: sorafenib tosylate
Given PO
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN
Drug: cytarabine
Given IT or IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be newly diagnosed with de novo acute myelogenous leukemia
  • Patients with previously untreated primary AML who meet the customary criteria for AML with >= 20% bone marrow blasts as set out in the 2008 World Health Organization (WHO) Myeloid Neoplasm Classification are eligible

    • Attempts to obtain bone marrow either by aspirate or biopsy must be made unless clinically prohibitive; in cases where it is clinically prohibitive, peripheral blood with an excess of 20% blasts and in which adequate flow cytometric and cytogenetics/fluorescent in situ hybridization (FISH) testing is feasible can be substituted for the marrow exam at diagnosis
  • Patients with < 20% bone marrow blasts are eligible if they have:

    • A karyotypic abnormality characteristic of de novo AML (t(8;21)(q22;q22), inv(16)(p13q22) or t(16;16)(p13;q22) or 11q23 abnormalities)
    • The unequivocal presence of megakaryoblasts, or
    • Biopsy proven isolated myeloid sarcoma (myeloblastoma; chloroma, including leukemia cutis)
  • Patients with any performance status are eligible for enrollment
  • Prior therapy with hydroxyurea, all-trans retinoic acid (ATRA), corticosteroids (any route), and IT cytarabine given at diagnosis is allowed

    • Hydroxyurea and ATRA must be discontinued prior to initiation of protocol therapy
    • Patients who have previously received any other chemotherapy, radiation therapy or any other antileukemic therapy are not eligible for this protocol
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

  • Patients with any of the following constitutional conditions are not eligible:

    • Fanconi anemia
    • Shwachman syndrome
    • Any other known bone marrow failure syndrome
    • Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Note: Enrollment may occur pending results of clinically indicated studies to exclude these conditions
  • Patients with any of the following oncologic diagnoses are not eligible:

    • Any concurrent malignancy
    • Juvenile myelomonocytic leukemia (JMML)
    • Philadelphia chromosome positive AML
    • Biphenotypic or bilineal acute leukemia
    • Acute promyelocytic leukemia
    • Acute myeloid leukemia arising from myelodysplasia
    • Therapy-related myeloid neoplasms Note: Enrollment may occur pending results of clinically indicated studies to exclude these conditions
  • Pregnancy and breast feeding
  • Female patients who are pregnant are ineligible
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants
  • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
  • Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371981

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Alyssa T. Reddy    205-934-0309      
Principal Investigator: Alyssa T. Reddy         
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Alyssa T. Reddy    205-934-0309      
Principal Investigator: Alyssa T. Reddy         
University of South Alabama Active, not recruiting
Mobile, Alabama, United States, 36604
United States, Arizona
Cardon Children's Medical Center Recruiting
Mesa, Arizona, United States, 85202
Contact: Xiaxin Li    602-747-9738      
Principal Investigator: Xiaxin Li         
Phoenix Childrens Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Jessica Boklan    602-546-0920      
Principal Investigator: Jessica Boklan         
United States, Arkansas
University of Arkansas for Medical Sciences Withdrawn
Little Rock, Arkansas, United States, 72205
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202-3591
Contact: David L. Becton    501-364-7373      
Principal Investigator: David L. Becton         
United States, California
Southern California Permanente Medical Group Recruiting
Downey, California, United States, 90242
Contact: Robert M. Cooper    626-564-3455      
Principal Investigator: Robert M. Cooper         
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Theresa M. Harned    323-361-4110      
Principal Investigator: Theresa M. Harned         
Loma Linda University Medical Center Active, not recruiting
Loma Linda, California, United States, 92354
Miller Children's Hospital Recruiting
Long Beach, California, United States, 90806
Contact: Theodore Zwerdling    562-933-5437      
Principal Investigator: Theodore Zwerdling         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Fataneh (Fae) Majlessipour    310-423-8965      
Principal Investigator: Fataneh (Fae) Majlessipour         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas    323-361-4110      
Principal Investigator: Leo Mascarenhas         
Children's Hospital Central California Recruiting
Madera, California, United States, 93636-8762
Contact: Vonda L. Crouse    866-353-5437      
Principal Investigator: Vonda L. Crouse         
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Steven K. Bergstrom    626-564-3455      
Principal Investigator: Steven K. Bergstrom         
Children's Hospital and Research Center at Oakland Recruiting
Oakland, California, United States, 94609-1809
Contact: Carla B. Golden    510-450-7600      
Principal Investigator: Carla B. Golden         
Childrens Hospital of Orange County Recruiting
Orange, California, United States, 92868-3874
Contact: Violet Shen    714-997-3000      
Principal Investigator: Violet Shen         
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Neyssa M. Marina    650-498-7061    clinicaltrials@med.stanford.edu   
Principal Investigator: Neyssa M. Marina         
University of California at Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Jay Michael S. Balagtas    916-734-3089      
Principal Investigator: Jay Michael S. Balagtas         
Sutter General Hospital Recruiting
Sacramento, California, United States, 95816
Contact: Yung S. Yim    916-454-6500    cancerinfo@sutterhealth.org   
Principal Investigator: Yung S. Yim         
University of California San Francisco Medical Center-Parnassus Recruiting
San Francisco, California, United States, 94143
Contact: Mignon L. Loh    877-827-3222      
Principal Investigator: Mignon L. Loh         
Santa Barbara Cottage Hospital Recruiting
Santa Barbara, California, United States, 93102
Contact: Daniel J. Greenfield    805-682-7300      
Principal Investigator: Daniel J. Greenfield         
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: Joseph L. Lasky    888-662-8252      
Principal Investigator: Joseph L. Lasky         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Kelly W. Maloney    720-777-6672      
Principal Investigator: Kelly W. Maloney         
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Jennifer J. Clark    866-775-6246      
Principal Investigator: Jennifer J. Clark         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Michael S. Isakoff    860-545-9981      
Principal Investigator: Michael S. Isakoff         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Nina S. Kadan-Lottick    203-785-5702      
Principal Investigator: Nina S. Kadan-Lottick         
United States, Delaware
Alfred I duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Christopher N. Frantz    302-651-5755      
Principal Investigator: Christopher N. Frantz         
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Recruiting
Washington, District of Columbia, United States, 20057
Contact: Aziza T. Shad    202-444-0381      
Principal Investigator: Aziza T. Shad         
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Jeffrey S. Dome    202-884-2549      
Principal Investigator: Jeffrey S. Dome         
United States, Florida
Broward Health Medical Center Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Hector M. Rodriguez-Cortes    954-355-5346      
Principal Investigator: Hector M. Rodriguez-Cortes         
Golisano Children's Hospital of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33908
Contact: Emad K. Salman    239-343-5333      
Principal Investigator: Emad K. Salman         
Lee Memorial Health System Withdrawn
Fort Myers, Florida, United States, 33901
University of Florida Active, not recruiting
Gainesville, Florida, United States, 32610
Memorial Healthcare System - Joe DiMaggio Children's Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Iftikhar Hanif    954-265-2234      
Principal Investigator: Iftikhar Hanif         
Nemours Children's Clinic-Jacksonville South Recruiting
Jacksonville, Florida, United States, 32207
Contact: Scott M. Bradfield    904-697-3529      
Principal Investigator: Scott M. Bradfield         
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Julio C. Barredo    866-574-5124    Sylvester@emergingmed.com   
Principal Investigator: Julio C. Barredo         
Miami Children's Hospital Active, not recruiting
Miami, Florida, United States, 33155
Baptist Hospital of Miami Active, not recruiting
Miami, Florida, United States, 33176
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Ramamoorthy Nagasubramanian    407-650-7150      
Principal Investigator: Ramamoorthy Nagasubramanian         
Arnold Palmer Hospital for Children Recruiting
Orlando, Florida, United States, 32806
Contact: Vincent F. Giusti    321-841-7246    CancerClinicalTrials@orlandohealth.com   
Principal Investigator: Vincent F. Giusti         
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Fouad M. Hajjar    407-303-5623      
Principal Investigator: Fouad M. Hajjar         
Nemours Children's Clinic - Orlando Withdrawn
Orlando, Florida, United States, 32806
UF Cancer Center at Orlando Health Withdrawn
Orlando, Florida, United States, 32806
Nemours Children's Clinic - Pensacola Recruiting
Pensacola, Florida, United States, 32504
Contact: Jeffrey H. Schwartz    904-697-3529      
Principal Investigator: Jeffrey H. Schwartz         
All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Gregory A. Hale    727-767-2423    HamblinF@allkids.org   
Principal Investigator: Gregory A. Hale         
Saint Joseph Children's Hospital of Tampa Active, not recruiting
Tampa, Florida, United States, 33607
Saint Mary's Hospital Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Narayana Gowda    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Narayana Gowda         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: Glen Lew    404-785-1112      
Principal Investigator: Glen Lew         
Georgia Regents University Medical Center Recruiting
Augusta, Georgia, United States, 30912
Contact: Colleen H. McDonough    706-721-1663    cancer@georgiahealth.edu   
Principal Investigator: Colleen H. McDonough         
Memorial University Medical Center Active, not recruiting
Savannah, Georgia, United States, 31404
United States, Hawaii
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Robert W. Wilkinson    808-983-6090      
Principal Investigator: Robert W. Wilkinson         
University of Hawaii Cancer Center Withdrawn
Honolulu, Hawaii, United States, 96813
United States, Idaho
Saint Luke's Mountain States Tumor Institute Active, not recruiting
Boise, Idaho, United States, 83712
United States, Illinois
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary L. Schmidt    312-355-3046      
Principal Investigator: Mary L. Schmidt         
Lurie Children's Hospital-Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Nobuko Hijiya    773-880-4562      
Principal Investigator: Nobuko Hijiya         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Ricarchito B. Manera    708-226-4357      
Principal Investigator: Ricarchito B. Manera         
Advocate Children's Hospital-Oak Lawn Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Ammar Hayani    800-323-8622      
Principal Investigator: Ammar Hayani         
Advocate Lutheran General Hospital. Withdrawn
Park Ridge, Illinois, United States, 60068
Advocate Children's Hospital-Park Ridge Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Jong-Hyo Kwon    847-384-3621      
Principal Investigator: Jong-Hyo Kwon         
Southern Illinois University Recruiting
Springfield, Illinois, United States, 62702
Contact: Gregory P. Brandt    217-545-7929      
Principal Investigator: Gregory P. Brandt         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Robert J. Fallon    317-274-2552      
Principal Investigator: Robert J. Fallon         
Saint Vincent Hospital and Health Services Active, not recruiting
Indianapolis, Indiana, United States, 46260
United States, Iowa
Blank Children's Hospital Active, not recruiting
Des Moines, Iowa, United States, 50309
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Ayman A. El-Sheikh    800-237-1225      
Principal Investigator: Ayman A. El-Sheikh         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Lars M. Wagner    859-257-3379      
Principal Investigator: Lars M. Wagner         
Kosair Children's Hospital Active, not recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University Health Sciences Center Withdrawn
New Orleans, Louisiana, United States, 70112
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Craig Lotterman    888-562-4763      
Principal Investigator: Craig Lotterman         
Children's Hospital New Orleans Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Lolie C. Yu    504-894-5377      
Principal Investigator: Lolie C. Yu         
United States, Maine
Eastern Maine Medical Center Active, not recruiting
Bangor, Maine, United States, 04401
Maine Children's Cancer Program Recruiting
Scarborough, Maine, United States, 04074
Contact: Eric C. Larsen    207-396-8090    wrighd@mmc.org   
Principal Investigator: Eric C. Larsen         
United States, Maryland
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Joseph M. Wiley    410-601-6120    pridgely@lifebridgehealth.org   
Principal Investigator: Joseph M. Wiley         
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Patrick A. Brown    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Patrick A. Brown         
University of Maryland/Greenebaum Cancer Center Active, not recruiting
Baltimore, Maryland, United States, 21201
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: Anne B. Warwick    301-319-2100      
Principal Investigator: Anne B. Warwick         
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Howard J. Weinstein    877-726-5130      
Principal Investigator: Howard J. Weinstein         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Carlos Rodriguez-Galindo    866-790-4500      
Principal Investigator: Carlos Rodriguez-Galindo         
Floating Hospital for Children at Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Michael J. Kelly    617-636-5000    ContactUsCancerCenter@TuftsMedicalCenter.org   
Principal Investigator: Michael J. Kelly         
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Christopher P. Keuker    508-856-3216    cancer.research@umassmed.edu   
Principal Investigator: Christopher P. Keuker         
United States, Michigan
C S Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Rajen Mody    800-865-1125      
Principal Investigator: Rajen Mody         
Wayne State University/Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Jeffrey W. Taub    313-576-9363      
Principal Investigator: Jeffrey W. Taub         
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Hadi Sawaf    313-343-3166      
Principal Investigator: Hadi Sawaf         
Michigan State University Clinical Center Active, not recruiting
East Lansing, Michigan, United States, 48824-7016
Helen DeVos Children's Hospital at Spectrum Health Active, not recruiting
Grand Rapids, Michigan, United States, 49503
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Katharina E. Elliott    800-227-2345      
Principal Investigator: Katharina E. Elliott         
Beaumont Children's Hospital-Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Laura K. Gowans    248-551-7695      
Principal Investigator: Laura K. Gowans         
United States, Minnesota
University of Minnesota Medical Center-Fairview Active, not recruiting
Minneapolis, Minnesota, United States, 55455
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Bruce C. Bostrom    612-813-5193      
Principal Investigator: Bruce C. Bostrom         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Carola A. Arndt    507-538-7623      
Principal Investigator: Carola A. Arndt         
United States, Mississippi
University of Mississippi Medical Center Active, not recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
Columbia Regional Active, not recruiting
Columbia, Missouri, United States, 65201
The Childrens Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Maxine L. Hetherington    816-234-3265      
Principal Investigator: Maxine L. Hetherington         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Robert J. Hayashi    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Robert J. Hayashi         
Saint John's Mercy Medical Center Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Bethany G. Sleckman    913-948-5588      
Principal Investigator: Bethany G. Sleckman         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Peter F. Coccia    800-999-5465      
Principal Investigator: Peter F. Coccia         
Children's Hospital and Medical Center of Omaha Recruiting
Omaha, Nebraska, United States, 68114
Contact: Minnie Abromowitch    402-955-3949      
Principal Investigator: Minnie Abromowitch         
United States, Nevada
Summerlin Hospital Medical Center Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Jonathan Bernstein    702-384-0013      
Principal Investigator: Jonathan Bernstein         
Children's Specialty Center of Nevada II Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Jonathan Bernstein    702-384-0013      
Principal Investigator: Jonathan Bernstein         
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Jonathan Bernstein    702-384-0013      
Principal Investigator: Jonathan Bernstein         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Sara Chaffee    800-639-6918    cancer.research.nurse@dartmouth.edu   
Principal Investigator: Sara Chaffee         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Burton E. Appel    201-996-2879      
Principal Investigator: Burton E. Appel         
Saint Barnabas Medical Center Terminated
Livingston, New Jersey, United States, 07039
Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Steven L. Halpern    973-971-5900      
Principal Investigator: Steven L. Halpern         
Saint Peter's University Hospital Active, not recruiting
New Brunswick, New Jersey, United States, 08901
UMDNJ - Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Richard A. Drachtman    732-235-8675      
Principal Investigator: Richard A. Drachtman         
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Peri Kamalakar    973-926-7230      
Principal Investigator: Peri Kamalakar         
Saint Joseph's Regional Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Mary A. Bonilla    973-754-2909      
Principal Investigator: Mary A. Bonilla         
Overlook Hospital Recruiting
Summit, New Jersey, United States, 07902
Contact: Steven L. Halpern    973-971-5900      
Principal Investigator: Steven L. Halpern         
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Richard Aplenc    240-276-6515      
Principal Investigator: Richard Aplenc         
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Koh B. Boayue    505-272-6972      
Principal Investigator: Koh B. Boayue         
United States, New York
Albany Medical Center Active, not recruiting
Albany, New York, United States, 12208
Montefiore Medical Center - Moses Campus Recruiting
Bronx, New York, United States, 10467-2490
Contact: Peter D. Cole    718-904-2730    aecc@aecom.yu.edu   
Principal Investigator: Peter D. Cole         
Roswell Park Cancer Institute Active, not recruiting
Buffalo, New York, United States, 14263
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Mark E. Weinblatt    866-946-8476      
Principal Investigator: Mark E. Weinblatt         
The Steven and Alexandra Cohen Children's Medical Center of New York Recruiting
New Hyde Park, New York, United States, 11040
Contact: Arlene S. Redner    718-470-3470      
Principal Investigator: Arlene S. Redner         
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10065
Contact: Alexander Aledo    212-746-1848      
Principal Investigator: Alexander Aledo         
New York University Langone Medical Center Active, not recruiting
New York, New York, United States, 10016
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Birte Wistinghausen    212-824-7320    jenny.figueroa@mssm.edu   
Principal Investigator: Birte Wistinghausen         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Alice Lee    212-305-8615      
Principal Investigator: Alice Lee         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Jeffrey R. Andolina    585-275-5830      
Principal Investigator: Jeffrey R. Andolina         
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Karol H. Kerr    315-464-5476      
Principal Investigator: Karol H. Kerr         
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Mehmet F. Ozkaynak    914-594-3794      
Principal Investigator: Mehmet F. Ozkaynak         
United States, North Carolina
Mission Hospital-Memorial Campus Recruiting
Asheville, North Carolina, United States, 28801
Contact: Douglas J. Scothorn    828-213-4150      
Principal Investigator: Douglas J. Scothorn         
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Stuart H. Gold    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Stuart H. Gold         
Novant Health Presbyterian Medical Center Active, not recruiting
Charlotte, North Carolina, United States, 28204
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Joel A. Kaplan    704-355-2884      
Principal Investigator: Joel A. Kaplan         
Duke University Medical Center Active, not recruiting
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Thomas W. McLean    336-713-6771      
Principal Investigator: Thomas W. McLean         
United States, North Dakota
Sanford Medical Center-Fargo Recruiting
Fargo, North Dakota, United States, 58122
Contact: Nathan L. Kobrinsky    701-234-6161      
Principal Investigator: Nathan L. Kobrinsky         
United States, Ohio
Children's Hospital Medical Center of Akron Recruiting
Akron, Ohio, United States, 44308
Contact: Steven J. Kuerbitz    330-543-3193      
Principal Investigator: Steven J. Kuerbitz         
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: John P. Perentesis    513-636-2799      
Principal Investigator: John P. Perentesis         
Rainbow Babies and Childrens Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Yousif (Joe) H. Matloub    216-844-5437      
Principal Investigator: Yousif (Joe) H. Matloub         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Margaret C. Thompson    866-223-8100      
Principal Investigator: Margaret C. Thompson         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Mark A. Ranalli    614-722-2708      
Principal Investigator: Mark A. Ranalli         
Dayton Children's Hospital Recruiting
Dayton, Ohio, United States, 45404
Contact: Emmett H. Broxson    800-228-4055      
Principal Investigator: Emmett H. Broxson         
The Toledo Hospital/Toledo Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Jamie L. Dargart    419-824-1842      
Principal Investigator: Jamie L. Dargart         
Mercy Children's Hospital Active, not recruiting
Toledo, Ohio, United States, 43608
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rene Y. McNall-Knapp    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Rene Y. McNall-Knapp         
United States, Oregon
Legacy Emanuel Children's Hospital Recruiting
Portland, Oregon, United States, 97227
Contact: Janice F. Olson    503-413-2560      
Principal Investigator: Janice F. Olson         
Legacy Emanuel Hospital and Health Center Recruiting
Portland, Oregon, United States, 97227
Contact: Janice F. Olson    503-413-2560      
Principal Investigator: Janice F. Olson         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Linda C. Stork    503-494-1080    trials@ohsu.edu   
Principal Investigator: Linda C. Stork         
United States, Pennsylvania
Lehigh Valley Hospital - Muhlenberg Recruiting
Bethlehem, Pennsylvania, United States, 18017
Contact: Philip M. Monteleone    484-884-2201      
Principal Investigator: Philip M. Monteleone         
Geisinger Medical Center Active, not recruiting
Danville, Pennsylvania, United States, 17822-2001
Penn State Hershey Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Lisa M. McGregor    717-531-6012      
Principal Investigator: Lisa M. McGregor         
Saint Christopher's Hospital for Children Active, not recruiting
Philadelphia, Pennsylvania, United States, 19134
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Richard Aplenc    215-590-2810      
Principal Investigator: Richard Aplenc         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Rakesh K. Goyal    412-692-5573      
Principal Investigator: Rakesh K. Goyal         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Jennifer J. Greene Welch    401-444-1488      
Principal Investigator: Jennifer J. Greene Welch         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jacqueline M. Kraveka    843-792-9321      
Principal Investigator: Jacqueline M. Kraveka         
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
Contact: Ronnie W. Neuberg    803-434-3680      
Principal Investigator: Ronnie W. Neuberg         
BI-LO Charities Children's Cancer Center Active, not recruiting
Greenville, South Carolina, United States, 29605
United States, South Dakota
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Kayelyn J. Wagner    605-328-1367      
Principal Investigator: Kayelyn J. Wagner         
United States, Tennessee
T C Thompson Children's Hospital Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Manoo G. Bhakta    423-778-7289      
Principal Investigator: Manoo G. Bhakta         
East Tennessee Childrens Hospital Active, not recruiting
Knoxville, Tennessee, United States, 37916
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Haydar A. Frangoul    800-811-8480      
Principal Investigator: Haydar A. Frangoul         
United States, Texas
Dell Children's Medical Center of Central Texas Recruiting
Austin, Texas, United States, 78723
Contact: Sharon K. Lockhart    512-324-8022      
Principal Investigator: Sharon K. Lockhart         
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: M. C. Johnson    361-694-5311      
Principal Investigator: M. C. Johnson         
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Tamra L. Slone    214-648-7097      
Principal Investigator: Tamra L. Slone         
Medical City Dallas Hospital Active, not recruiting
Dallas, Texas, United States, 75230
Brooke Army Medical Center Active, not recruiting
Fort Sam Houston, Texas, United States, 78234
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Kenneth M. Heym    682-885-2103      
Principal Investigator: Kenneth M. Heym         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Karen R. Rabin    713-798-1354    burton@bcm.edu   
Principal Investigator: Karen R. Rabin         
Covenant Children's Hospital Recruiting
Lubbock, Texas, United States, 79410
Contact: Latha Prasannan    806-725-8000    jaccresearch@covhs.org   
Principal Investigator: Latha Prasannan         
Methodist Children's Hospital of South Texas Recruiting
San Antonio, Texas, United States, 78229
Contact: Jaime Estrada    210-575-7000      
Principal Investigator: Jaime Estrada         
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Anne-Marie R. Langevin    210-450-3800    CTO@uthscsa.edu   
Principal Investigator: Anne-Marie R. Langevin         
Children's Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Timothy C. Griffin    800-284-7370      
Principal Investigator: Timothy C. Griffin         
Scott and White Memorial Hospital Active, not recruiting
Temple, Texas, United States, 76508
United States, Utah
Primary Children's Hospital Active, not recruiting
Salt Lake City, Utah, United States, 84113
United States, Vermont
University of Vermont Active, not recruiting
Burlington, Vermont, United States, 05401
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Marshall A. Schorin    703-208-6650      
Principal Investigator: Marshall A. Schorin         
Childrens Hospital-King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Eric J. Lowe    757-668-7243      
Principal Investigator: Eric J. Lowe         
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Christina M. Wiedl    804-628-1939      
Principal Investigator: Christina M. Wiedl         
Carilion Clinic Children's Hospital Recruiting
Roanoke, Virginia, United States, 24014
Contact: Mandy M. Atkinson    540-981-7376      
Principal Investigator: Mandy M. Atkinson         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Douglas S. Hawkins    866-987-2000      
Principal Investigator: Douglas S. Hawkins         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Judy L. Felgenhauer    800-228-6618    HopeBeginsHere@providence.org   
Principal Investigator: Judy L. Felgenhauer         
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Melissa A. Forouhar    253-968-0129    mamcdci@amedd.army.mil   
Principal Investigator: Melissa A. Forouhar         
Mary Bridge Children's Hospital and Health Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Robert G. Irwin    253-403-3229      
Principal Investigator: Robert G. Irwin         
United States, West Virginia
West Virginia University Charleston Recruiting
Charleston, West Virginia, United States, 25304
Contact: Howard M. Grodman    304-388-9944      
Principal Investigator: Howard M. Grodman         
United States, Wisconsin
Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: John R. Hill    920-433-8889      
Principal Investigator: John R. Hill         
University of Wisconsin Hospital and Clinics Active, not recruiting
Madison, Wisconsin, United States, 53792
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Michael J. McManus    715-389-4457      
Principal Investigator: Michael J. McManus         
Midwest Children's Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Michael E. Kelly    414-805-4380      
Principal Investigator: Michael E. Kelly         
Australia, New South Wales
John Hunter Children's Hospital Recruiting
Hunter Regional Mail Centre, New South Wales, Australia, 2310
Contact: Draga Barbaric    (02) 9382-1721      
Principal Investigator: Draga Barbaric         
Sydney Children's Hospital Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Draga Barbaric    (02) 9382-1721      
Principal Investigator: Draga Barbaric         
The Children's Hospital at Westmead Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Geoffrey B. McCowage    61-2-9845 1400      
Principal Investigator: Geoffrey B. McCowage         
Australia, Queensland
Royal Childrens Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact: Helen Irving    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Helen Irving         
Royal Brisbane and Women's Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact: Helen Irving    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Helen Irving         
Australia, Victoria
Royal Children's Hospital Recruiting
Parkville, Victoria, Australia, 3052
Contact: Francoise M. Mechinaud       crdo.info@mcri.edu.au   
Principal Investigator: Francoise M. Mechinaud         
Australia, Western Australia
Princess Margaret Hospital for Children Recruiting
Perth, Western Australia, Australia, 6008
Contact: Catherine H. Cole    (08) 9340 8330    admin@childcancerresearch.com.au   
Principal Investigator: Catherine H. Cole         
Canada, Alberta
Alberta Children's Hospital Active, not recruiting
Calgary, Alberta, Canada, T3B 6A8
Canada, British Columbia
British Columbia Children's Hospital Active, not recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba Active, not recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Janeway Child Health Centre Active, not recruiting
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre Active, not recruiting
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
Chedoke-McMaster Hospitals Recruiting
Hamilton, Ontario, Canada, L8S 4L8
Contact: Carol Portwine    905-521-2100ext74595      
Principal Investigator: Carol Portwine         
McMaster Children's Hospital at Hamilton Health Sciences Active, not recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Cancer Centre of Southeastern Ontario at Kingston General Hospital Active, not recruiting
Kingston, Ontario, Canada, K7L 5P9
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Jacqueline M. Halton    613-738-3931      
Principal Investigator: Jacqueline M. Halton         
Hospital for Sick Children Active, not recruiting
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Centre Hospitalier Universitaire Sainte-Justine Active, not recruiting
Montreal, Quebec, Canada, H3T 1C5
The Montreal Children's Hospital of the MUHC Active, not recruiting
Montreal, Quebec, Canada, H3H 1P3
Centre Hospitalier Universitaire de Quebec Active, not recruiting
Ste-Foy, Quebec, Canada, G1V 4G2
New Zealand
Starship Children's Hospital Active, not recruiting
Grafton, Auckland, New Zealand, 1145
Christchurch Hospital Active, not recruiting
Christchurch, New Zealand, 8011
Puerto Rico
San Jorge Children's Hospital Active, not recruiting
San Juan, Puerto Rico, 00912
Sponsors and Collaborators
Investigators
Principal Investigator: Richard Aplenc Children's Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01371981     History of Changes
Other Study ID Numbers: NCI-2011-02670, NCI-2011-02670, COG-AAML1031, CDR0000701850, AAML1031, AAML1031, U10CA180886, U10CA098543
Study First Received: June 10, 2011
Last Updated: October 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Erythroblastic, Acute
Leukemia, Megakaryoblastic, Acute
Leukemia, Monocytic, Acute
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Bone Marrow Diseases
Hematologic Diseases
Myelodysplastic-Myeloproliferative Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Asparaginase
Bortezomib
Cytarabine
Daunorubicin
Etoposide
Etoposide phosphate
Mitoxantrone
Niacinamide
Sorafenib
Analgesics
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 22, 2014