Oxaliplatin, Fludarabine, Cytarabine and Rituximab in Richter's Syndrome, Refractory CLL and PLL
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
Summary
Primary Objectives:
1. Determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of
oxaliplatin in combination with fludarabine, Ara-C and rituximab in patients with
Richter's transformation, prolymphocytic leukemia (PLL), or refractory/relapsed B-cell
chronic lymphocytic leukemia (CLL).
2. Assess the complete response (CR) and partial response (PR) rate to combination therapy
of oxaliplatin, fludarabine, Ara-C and rituximab in patients with Richter's
transformation, PLL or refractory/relapsed B-cell CLL.
3. Determine the safety and toxicity profile of combination therapy of oxaliplatin,
fludarabine, Ara-C and rituximab in patients with Richter's transformation, PLL or
refractory/relapsed B-cell CLL.
Secondary Objectives:
1. Determine the duration of response, failure-free survival, and overall survival.
2. Determine the incidence of infections (bacterial, fungal, and viral) in patients with
Richter's transformation, prolymphocytic leukemia or refractory/relapsed B-cell CLL
treated with rituximab, oxaliplatin, fludarabine and Ara-C; monitor immune parameters
such as T cell counts and immunoglobulin levels; and monitor Epstein-Barr virus (EBV)
status.
3. Characterize the pharmacodynamics of oxaliplatin in leukemia cells with respect to total
adduct formation, cross-link formation and excision deoxyribonucleic acid (DNA)
responses. Compare these parameters in cells from the same patient after treatment with
oxaliplatin in combination with fludarabine and Ara-C.