Phase II Trial of Dasatinib With Fludarabine and Rituximab in Relapsed and Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
- Since the purpose of the study is to determine the response rate of the 3 drug regimen,
everyone who participates will receive the same dose of the study drug, dasatinib and
the 2 standard drugs, fludarabine and rituximab.
- Participants will receive the drugs dasatinib, fludarabine, and rituximab at the
following time points through each cycle of treatment. A cycle of study treatment is
28 days. Dasatinib pills will be taken orally each day for the first 2 weeks of each
cycle. Fludarabine will be give intravenously on three days of each cycle (Days 3-5 in
the first cycle, days 1-3 after that). Rituximab will be given intravenously with a
total dose of 375 mg/m2 each cycle (split on Days 3+4 in the first cycle and at the
discretion of the treating physician after that on Days 1-3).
- The following procedures will be repeated throughout the study: medical history
review; physical exam; performance status test; blood tests and EKG. They will occur
daily during the first week of treatment, then weekly for the rest of cycle 1. After
cycle 1 these procedures will be done once a week for 4 weeks then once a month for 6
- Tumor assessments will be repeated once every 2 months for the first six months of the
study, and then once every 6 months after that.
- Blood samples will be obtained in the first 5 days of treatment for pharmacokinetic
studies and pharmacodynamic studies.
- Participants that are benefiting from the study treatment after the first cycle can
continue to receive an additional 6 cycles of study treatment.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To describe the response rate of complete respone and partial response to treatment with this drug combination.
Philip Amrein, MD
Massachusetts General Hospital
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|