A Phase III Study of Clofarabine versus Standard Therapy for Newly Diagnosed Acute Myeloid Leukemia in Older Adults

Protocol
12-059
Full 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 = 60 Years) (ECOG #E2906)
Phase
III
Disease Status
Newly Diagnosed
Purpose

Daunorubicin plus cytarabine is the standard treatment for acute myelogenous leukemia (AML) and has helped improve the outcome for younger patients. However, this therapy is not as effective for treating AML in older adults (age 60 and older), and is associated with side effects that may be difficult for some older individuals to tolerate.

In this study, researchers are comparing the safety and effectiveness of clofarabine with standard daunorubicin/cytarabine therapy in newly diagnosed older adults with AML. Clofarabine is already commonly used to treat acute lymphoblastic leukemia in children and adolescents, but its use for treating older adults with AML is considered investigational.

Patients in this study will be randomly assigned to begin treatment (induction therapy) with either clofarabine or with daunorubicin/cytarabine. In the second part of the study (consolidation therapy), patients will then be randomly assigned to receive cytarabine, clofarabine, or a bone marrow transplant to reduce the risk of relapse. In the third part of the study, patients will then be randomly assigned to receive decitabine as maintenance therapy or to be observed (no maintenance treatment).

Co-Investigators
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have newly diagnosed AML.
  • Patients must be age 60 or older.
  • Patients may not have had prior therapy for AML.

For more information about this study and to inquire about eligibility, please contact Dr. Martin Tallman at 212-639-3842.

Disease(s)
Leukemia
Leukemia: Acute Myelocytic Leukemia
Leukemia: Acute Myelogenous Leukemia
Locations