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Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00528398
First received: September 10, 2007
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose cytarabine works in treating patients with acute myeloid leukemia.


Condition Intervention Phase
Leukemia
 Drug: cytarabine
Drug: idarubicin
 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 Trial Utilizing Idarubicin in Combination With High Dose Ara-C for Induction Therapy for Adult Acute Myelogenous Leukemia (AML)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Complete remission (CR) rate [ Time Frame: Up to 20 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 195
Study Start Date: March 1994
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (idarubicin, cytarabine)
Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with > 25% cellular biopsy or > 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.
 Drug: cytarabine Drug: idarubicin

Detailed Description:

OBJECTIVES:

  • Determine the complete remission rate (CR), and compare this rate to the historical control group rate of 79% from our previous study achieved utilizing high-dose cytarabine and daunorubicin.
  • Determine the proportion of patients who are bone marrow-positive at day 7 post-induction chemotherapy, and compare this rate to the historical control group rate of 20%.
  • Determine the ability of patients treated with this regimen to receive further post-remission chemotherapy, and compare this rate to historical control group rate of 81% among 79 patients achieving CR in our previous study.
  • Further evaluate the toxicity of this regimen, and contrast this with our previous study results.
  • Determine the effect of prognostic variables on achieving a complete remission (e.g., age, WBC, FAB type, cytogenetics, and CD34).
  • Describe the CR rate, proportion of patients whose bone marrow is positive at day 7 post-induction chemotherapy, ability to receive further post-remission chemotherapy, and toxicity in 2 subgroups of patients (patients with prior myelodysplastic syndrome and patients with treatment-related leukemia).

OUTLINE: Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with > 25% cellular biopsy or > 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Newly diagnosed acute myeloid leukemia (AML)

    • Morphologic proof (bone marrow aspirate smears or touch prep of marrow biopsy) of disease
    • FAB M0, M1, M2, M4, M5a, M5b, M6a, M6b, and M7 disease

  • Previously untreated with radiotherapy or chemotherapy

    • Patients with treatment-related leukemia are eligible even if they have received prior chemotherapy and radiotherapy
  • Patients with prior myelodysplastic syndrome are eligible
  • Extramedullary leukemia allowed
  • AML with lymphoid markers allowed

Exclusion criteria:

  • Blastic transformation of chronic myelogenous leukemia
  • Biphenotypic leukemia
  • FAB M3 disease (acute promyelocytic leukemia)

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 6 weeks
  • Total bilirubin < 1.5 g/dL
  • AST and ALT < 5 times upper limit of normal (ULN)
  • Creatinine < 1.5 mg/dL OR creatinine clearance > 70 mL/min
  • Ejection fraction ≥ 50% by MUGA unless decreased ejection fraction is secondary to leukemia infiltration
  • HIV antibody-negative

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

  • See Disease Characteristics
  • Prior hydroxyurea or corticosteroids allowed
  • At least 48 hours since prior and no concurrent itraconazole or fluconazole

Exclusion criteria:

  • More than 300 mg/m² of prior daunorubicin or equivalent dose of anthracycline
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528398

Locations
United States, Arizona
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Anthony S. Stein, MD Beckman Research Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00528398     History of Changes
Other Study ID Numbers: 93139, P30CA033572, CHNMC-93139, CHNMC-93139-94-03-1, CDR0000564537
Study First Received: September 10, 2007
Last Updated: February 14, 2013
Health Authority: United States: Federal Government

Keywords provided by City of Hope Medical Center:
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 myelomonocytic leukemia (M4)
adult erythroleukemia (M6a)
 adult pure erythroid leukemia (M6b)
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)
secondary acute myeloid leukemia
untreated adult acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on May 16, 2013