At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed Richter's transformation, prolymphocytic leukemia, aggressive, or relapsed/refractory B-cell chronic lymphocytic leukemia
- ✓Age ≥18 years
- ✓ECOG performance status 0-2 (Zubrod scale)
- ✓Adequate renal function: serum creatinine ≤2 mg/dL or creatinine clearance >50 mL/min
- ✕Untreated or uncontrolled life-threatening infection
- ✕Intolerance to oxaliplatin, fludarabine, cytarabine, or rituximab
- ✕Pregnancy or lactation
- ✕Chemotherapy and/or radiation therapy within 4 weeks
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I-II Study of Oxaliplatin, Fludarabine, Cytarabine, and Rituximab in Patients With Richter's Transformation, Prolymphocytic Leukemia, Aggressive, Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
In Brief
A Phase 2 clinical trial evaluating Oxaliplatin, Fludarabine, and 3 other interventions for Richter's Transformation and Leukemia. Completed, enrolled 92 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Oxaliplatin 30 mg/m\^2/day, over approximately 2 hours, before fludarabine is started, on days 1-4.
Fludarabine 30 mg/m\^2 daily IV, over approximately 30 minutes, on days 2-3, 2-4, or 2-5 until maximum tolerated dose is reached.
Cytarabine 500 mg/m\^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose is started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose is reached.
Rituximab 375 mg/m\^2 IV on day 3, course 1 (on day 1, subsequent courses).
6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy