S0805 Phase II Study of Combination of Hyper-CVAD and Dasatinib (NSC-732517) with or without Allogeneic Stem Cell Transplant in Patients with Philadelphia (Ph) Chromosome Positive and/or Bcr-Abl Positive Acute Lymphoblastic Leukemia (ALL)
1. To see whether the relapse-free survival of patients after this treatment is sufficiently high to warrant further investigation. 2. To see whether the continuous complete remission rate for previously untreated patientsis sufficiently high to warrant Phase III investigation. 3. To estimate the frequency and severity of toxicities of the intensive short- term chemotherapy regimen in these patients.
Must have a morphologic diagnosis of acute lymphoblastic leukemia with evidence of involvement in bone marrow and/or blood;received no more than one course of remission induction therapy for ALL; must be Philadelphia (Ph) chromosome positive and/or BCR/ABL positive; must have good liver and kidney function; must not have any fluid accumulation in chest or abdomen; must have good heart function; must be able to do most activities of daily living
1. Induction/Consolidation treatment consists of 9 courses of alternating therapies of Hyper-CVAD plus Dasatinib[(Cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone, Dasatinib, Methotrexate, Cytarabine)lasting 14-21 days]and High dose Methotrexate and Cytarabine plus Dasatinib [(Methotrexate, Methylprednisolone, Dasatinib, Cytarabine) lasting 14-21 days]. 2. For patients with an available stem cell donor after induction/consolidation, they will proceed directly to transplant and will not receive any Maintenance therapy. 3. For patient without an available stem cell donor after induction/consolidation, Maintenance therapy will begin consisting of up to 24 courses of VIncristine, Prednisone and Dasatinib. Each course will last 28 days. There may also be 2 course of Hyper-CVAD plus Dasatinib (as descibed above) during courses 6 and 13 which will be determined by the doctor. Maintanence will continue until their transplant is available or after the completion of 24 courses. 4. Post-transplant/Post-Maintenance Therapy occurs for those who reach Day 100 post transplant or those who complete Maintanence/Intensification therapy. Therapy consists of Dasatinib 100 mg orally once a day for up to five years from the day originally started on study.
06/18/2013 04:02 AM