(SWOG S0805) Phase II Study of Combination of Hyper-CVAD and Dasatinib With or Without Allogenetic Stem Cell Transplant in Patients with Philadelphia (Ph) Chromosome Positive and/or Bcr-Abl Positive Acute Lymphoblastic Leu...
Title (SWOG S0805) Phase II Study of Combination of Hyper-CVAD and Dasatinib With or Without Allogenetic Stem Cell Transplant in Patients with Philadelphia (Ph) Chromosome Positive and/or Bcr-Abl Positive Acute Lymphoblastic Leukemia (ALL)(A BMT Study)
Contact WWendy
Principal Investigator Meir Wetzler, MD
Study Number 203511
Phase2
Summary The purpose of this study is to find out what effects the investigational drug dasatinib has on Acute Lymphocytic Leukemia (ALL). Dasatinib is approved for use in the treatment of chronic myeloid leukemia and resistant Philadelphia chromosome positive ALL but is investigational as it is used on this study. The study would like to determine what effects of dasatinib in combination with drugs that are usually given as standard of care will have with or without a stem cell transplant.
Eligibility
- Patients must have a morphologic diagnosis of acute lymphoblastic leukeima(ALL).
- Patients may have received no more than one course of remission induction therapy for ALL, providing this induction course was given prior to the results of the cytogenetics testing for Ph/BCR/ABL status being known.
- For patients who have received any prior therapy that was NOT remission induction therapy, one of the following must be true:
- Patients must be Philadephia chromosome positive and/or BCR/ABL positive as confirmed by standard cytogenetics, FISH,and/or polymerase chain reaction performed by local laboratory
- At least 6 wks must have elapsed since any monoclonal antibodies were given, at least 7 days must have elapsed since any other treatment was given
- No other prior malignancy is allowed except for the following: adequately treated Stage I or II cancer from which patient is currently in complete remission, or any other cancer from which the patient has been disease free for 5 years.
Maintenance/Intensification:
- Patient must have achieved CR or Cri within 2 courses of Induction/Consolidation Chemotherapy. Patients must not have received allogeneic stem cell transplant.
Transplant Registration:
- Patients must have an avaiable completely matched sibling donor or a 10/10 matched non-sibling donor.
