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Clinical Trial ECOGHEME2906

Title

Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin & Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age greater than or equal to 60 Years)

Principal Investigator(s)

Stephen Strickland

Details

  • Protocol No. ECOGHEME2906
  • Open Date: 01/20/2012
  • Staging: Phase III
  • Age Group: Adults
  • Scope: National
  • Objective: To evaluate the effect of clofarabine induction and consolidation therapy on overall survival in comparison with standard therapy (daunorubicin & cytarabine) in newly diagnosed AML patients age greater than or equal to 60 years.
  • Disease Sites: Leukemia
  • Therapies: Bone Marrow/Stem Cell Transplant; Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Clofarabine; Cytarabine (ARA-C); Daunorubicin (Daunomycin); Decitabine; Dexamethasone
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01041703
  • Secondary Protocol No: E2906

Description

This study is being done to determine which treatment is best for older patients with newly diagnosed Acute Myeloid Leukemia (AML).

Eligibility

Ages Eligible for Study:60 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

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