ECOG E2906: Phase 3 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 >= 60 Years)

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ECOG E2906: Phase 3 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 >= 60 Years)

Primary Objective
2.1.1 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 ? 60 years.
2.2 Secondary Objectives
2.2.1 To evaluate complete remission (CR) rates, duration of remission, and toxicity/treatment-related mortality of clofarabine in comparison with standard therapy (daunorubicin & cytarabine) in newly-diagnosed AML patients age >60 years.
2.2.2 To evaluate the feasibility of consolidation with reduced-intensity conditioning and allogeneic hematopoietic stem cell transplantation from HLA-identical donors in select patients age 60-69 years who achieve a response to induction therapy, including the incidence of successful engraftment, acute and chronic graft-versus-host disease, transplant-related mortality, and its impact on overall survival in comparison to patients receiving chemotherapy.
2.2.3 To evaluate the duration of remission and disease-free survival of patients in complete remission following completion of consolidation therapy who are subsequently randomized to receive scheduled low-dose decitabine maintenance in comparison with observation.
Other Objectives include examination of several molecular correlates including methylation profiles, p-glycoprptein and CXCr4 expression, analyzing somatic mutations.

Protocol Number021302
Principal InvestigatorDale Schaar
PhasePhase III
ScopeNational
Applicable Disease SitesMyeloid and Monocytic Leukemia
Therapies InvolvedChemotherapy single agent systemic
Chemotherapy multiple agents systemic
Drugs InvolvedClofarabine
Decitabine (Dacogen)
DAUNORUBICIN
CYTARABINE
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.