A Phase II Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy Plus Dasatinib (NSC# 732517, IND#73969) and Continuation Therapy with Dasatinib Alone in Newly Diagnosed patient...
Title A Phase II Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy Plus Dasatinib (NSC# 732517, IND#73969) and Continuation Therapy with Dasatinib Alone in Newly Diagnosed patients with Core Binding Factor Acute Myeloid Leukemia(AML)
Contact TH
Principal Investigator Meir Wetzler, MD
Study Number 199311
Phase2
Summary
The purpose of this study is to test the safety and effectiveness of the addition of the drug dasatinib to a treatment regimen for patients with AML, and to see what effects (good and bad) dasatinib has on leukemia. Dasatinib can block the activity of the mutated KIT gene in leukemia cells. There are three parts to the treatment in this study. The first part of the therapy will test the safety and effectiveness of adding dasatinib to the standard combination of chemotherapy drugs used to treat AML that includes daunorubicin and cytarabine. High-dose cytarabine (abbreviated as HiDAC) is a higher dose of cytarabine than that used during the first portion of therapy. Finally, the third part of the therapy will test the effectiveness of the use of dasatinib alone for 12 months during continuation therapy. Each part of the therapy will be described in detain below. Dasatinib has been approved by the Food and Drug Administration (FDA) for patients with chronic myeloid leukemia (CML), another form of leukemia, whose disease has recurred or returned despite previous treatment. Patients with CML have taken daily doses of dasatinib for several years to control their leukemia. However, the use of dasatinib to treat AML is experimental. Daunorubicin and cytarabine are approved for use by the FDA in patients diagnosed with AML. This research is being done because currently available treatment is not effective in curing all patients with your type of leukemia. The results of this study will be closely correlated with important laboratory studies that will be conducted during the course of your treatment.
Eligibility
As assessed by the CALGB reference laboratory at the Ohio State University per CALGB 20202, molecular diagnosis of Core Binding Factor
No prior chemotherapy for leukemia or myelodysplasia with the following exceptions:
- Emergency leukapheresis
- Emergency treatment for hyperleukocytosis with hydroxyurea
- Cranial RT for CNS leukostasis (one dose only)
- Growth factor/cytokine support/non-cytotoxic molecular targeted agents
AML patients with a history of antecedent myelodysplasia (MDS) remain eligible for treatment on this trial.
Patients who have developed therapy related myeloid neoplasm (t-MN) after prior radiation therapy or chemotherapy for another cancer or disorder are eligible.
