drugset / Trial / NCT00472849

Oxaliplatin, Fludarabine, Cytarabine, and Rituximab in Patients With Richter's Transformation and Leukemias

NCT00472849

Phase 1/2 Completed 92 enrolled M.D. Anderson Cancer Center Sanofi · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to find the highest tolerable dose of fludarabine and cytarabine that can be given in combination with oxaliplatin and rituximab in the treatment of chronic lymphocytic leukemia (CLL), prolymphocytic leukemia, or Richter's transformation. Once the highest tolerable dose for this drug combination is found, the next goal of the study will be to find out if this combination therapy is effective in shrinking or slowing the growth of these diseases.

Timeline

Start
2007-05
Primary completion
2012-02
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 500 mg/m2 Intravenous
Subject Fludarabine Small molecule 30 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 25 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 30 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous