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Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00416598
First received: December 27, 2006
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

This phase II trial is studying the side effects and how well decitabine works when given as maintenance therapy after standard therapy in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin, etoposide, busulfan, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving decitabine as maintenance therapy after standard therapy may keep cancer cells from coming back


Condition Intervention Phase
Adult Acute Basophilic Leukemia
Adult Acute Eosinophilic Leukemia
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)
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
 Drug: daunorubicin hydrochloride
Procedure: autologous bone marrow transplantation
Drug: cytarabine
Drug: etoposide
Biological: filgrastim
Drug: busulfan
Drug: decitabine
Procedure: autologous hematopoietic stem cell transplantation
Other: laboratory biomarker analysis
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Maintenance Therapy With Decitabine (NSC #127716, IND #50733) Following Standard Induction and Cytogenetic Risk-Adapted Intensification in Previously Untreated Patients With AML < 60 Years

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Feasibility of maintenance decitabine administered to patients following intensive induction and consolidation chemotherapy, with or without autologous PSCT [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Disease-free survival (DFS) rate [ Time Frame: At 1 year ] [ Designated as safety issue: No ]
    This study design produces a Type I error rate of 0.082 with a power of 0.904 when the true 1-year DFS rate is 0.85.

  • Toxicity as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: From the beginning of treatment to up to 5 year ] [ Designated as safety issue: Yes ]
    For induction treatments, tabulation of toxicities will occur only for unexpected toxicities. For autologous transplantation, only unexpected toxicities will be tabulated, except for liver and pulmonary toxicities which will be completely summarized in order to facilitate investigation of IV busulfan-related toxicity events. For the decitabine portion of the study, comprehensive summaries of toxicities and adverse events will be tabulated.


Secondary Outcome Measures:
  • Relationship between busulfan pharmacokinetics (area under the curve) and relapsed disease [ Time Frame: At baseline, after 2, 4, and 6 hours after the start of busulfan infusion ] [ Designated as safety issue: No ]
    Results from busulfan pharmacokinetics will be pooled with those from CALGB 19808.


Estimated Enrollment: 500
Study Start Date: November 2006
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (chemotherapy, PBSC or bone marrow transplantation)

See Detailed Description:

Patients undergo induction therapy comprising cytarabine and daunorubicin hydrochloride. Patient with RD undergo second induction therapy comprising cytarabine, daunorubicin hydrochloride, and etoposide. Patients with CR and favorable cytogenetics who achieve CR receive intensification therapy comprising high-dose cytarabine. Patients with UC receive etoposide, high-dose cytarabine, G-CSF., and busulfan and proceed to PBSC or bone marrow transplantation. Patients with UC and unable to undergo transplantation receive etoposide, high-dose cytarabine, and G-CSF. Patients then receive decitabine as maintenance therapy.

 Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Procedure: autologous bone marrow transplantation
Undergo autologous bone marrow transplantation
Other Names:
  • ABMT
  • bone marrow transplantation, autologous
  • transplantation, autologous bone marrow
Drug: cytarabine
Given IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Biological: filgrastim
Given SC
Other Names:
  • G-CSF
  • Neupogen
Drug: busulfan
Given IV
Other Names:
  • BSF
  • BU
  • Misulfan
  • Mitosan
  • Myeloleukon
Drug: decitabine
Given IV
Other Names:
  • 5-aza-dCyd
  • 5AZA
  • DAC
Procedure: autologous hematopoietic stem cell transplantation
Undergo autologous PBSC transplantation
Other: laboratory biomarker analysis
Correlative studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed acute myeloid leukemia (AML)

    • More than 20% blasts in the bone marrow
    • Antecedent myelodysplasia allowed provided there is no bone marrow biopsy showing myelodysplastic syndromes more than 3 months prior to study entry
    • Therapy-related AML allowed provided patient has not had primary disease or received chemotherapy within the past 2 years
    • No M3 disease (acute promyelocytic leukemia)
  • Registered on CALGB-8461 and CALGB-20602
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior azacitidine or decitabine

  • No prior treatment for leukemia or myelodysplastic syndromes, except in the following circumstances:

    • Emergency leukapheresis
    • Emergency treatment for hyperleukocytosis with hydroxyurea
    • Cranial radiation therapy for CNS leukostasis (one dose only)
    • Growth factor/cytokine support
  • No other concurrent chemotherapy
  • No concurrent hormonal therapy except steroids for nausea, adrenal failure, or septic shock or hormones administered for nondisease-related conditions
  • No concurrent palliative radiation therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416598

  Show 38 Study Locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: William Blum Cancer and Leukemia Group B
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00416598     History of Changes
Obsolete Identifiers: NCT01647074
Other Study ID Numbers: NCI-2009-00444, CALGB 10503, U10CA031946
Study First Received: December 27, 2006
Last Updated: March 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Congenital Abnormalities
Leukemia
Leukemia, Basophilic, Acute
Leukemia, Eosinophilic, Acute
Leukemia, Erythroblastic, Acute
Leukemia, Megakaryoblastic, Acute
Leukemia, Monocytic, Acute
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Hypereosinophilic Syndrome
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
 Bone Marrow Diseases
Hematologic Diseases
Myelodysplastic-Myeloproliferative Diseases
Eosinophilia
Leukocyte Disorders
Busulfan
Cytarabine
Etoposide phosphate
Decitabine
Daunorubicin
Etoposide
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013