Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Status: Recruiting
Diagnosis: Lung Cancer
NCT ID: NCT01041703 (View complete trial on
DFCI Protocol ID: 13-031


RATIONALE: Drugs used in chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, 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 more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective in treating acute myeloid leukemia. PURPOSE: This randomized phase III trial is studying clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia.


Conducting Institutions:
Beth-Israel Deaconess Medical Center

Overall PI:
David Avigan, MD, Beth Israel Deaconess Medical Center

Site-responsible Investigators:

Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

DISEASE CHARACTERISTICS: - Newly diagnosed acute myeloid leukemia (AML) - Considered candidates for intensive chemotherapy based on examination of peripheral blood or bone marrow aspirate specimens or touch preparations of the bone marrow biopsy obtained within the past 2 weeks - Bone marrow aspirate is required for enrollment, however, if there is discordance between percentage of myeloblasts on the differential of the peripheral blood or aspirate, the peripheral blood criteria are sufficient for diagnosis - Patients with secondary AML (defined as AML that has developed in a person with a history of antecedent blood count abnormalities, myelodysplastic syndromes [MDS], or a myeloproliferative disorder [excluding chronic myeloid leukemia], or a history of prior chemotherapy or radiotherapy for a disease other than AML) are eligible - Patients with acute promyelocytic leukemia (APL) confirmed either by the presence of t(15;17)(q22;q21) or PML/RAR transcripts will be excluded - No blastic transformation of chronic myelogenous leukemia - No documented CNS involvement - Concurrent registration on ECOG-E3903 (Ancillary Laboratory Protocol for the Collecting of Diagnostic Samples from Patients With Leukemia or Related Hematologic Disorders Being Considered for ECOG Treatment Clinical Trials) required (except for patients participating at CTSU institutions; these patients are exempt from this requirement) - Cytogenetic analysis must be performed from diagnostic bone marrow (preferred) or if adequate number of circulating blasts (>10^9/L) from peripheral blood - Diagnostic bone marrow and peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing - Peripheral blood stem cell donor meeting 1 of the following criteria: - HLA-identical sibling (6/6) - Low-resolution HLA typing (A,B,DR) allowed - Matched unrelated donor (10/10) - High-resolution class I and II typing (A,B,C,DRB1 and DQ) should be matched at all 10 loci PATIENT CHARACTERISTICS: - ECOG performance status (PS) 0-3 (ECOG PS 0-2 if ≥ 70 years of age) - AST and ALT ≤ grade 1 - Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ grade 1) - Serum creatinine ≤ 1 mg/dL (≤ grade 1) - Cardiac ejection fraction ≥ 45% by MUGA or 2-D ECHO - Fertile patients must use effective contraception - No concurrent active malignancy requiring treatment (other than MDS) - No active, uncontrolled infection - No known HIV infection PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior chemotherapy for AML (except for hydroxyurea for increased blast count or leukapheresis for leukocytes) - No prior treatment with azacitidine, decitabine, or low-dose cytarabine
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