Phase 2
N=90
Oxaliplatin, Fludarabine, Cytarabine, and Rituximab in Patients With Richter's Transformation and Leukemias
Richter's Transformation · Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00472849 ↗Enrolled (actual)
90
Serious AEs
25.6%
Results posted
Nov 2013
Primary outcome: Primary: Maximum Total Tolerated Dose (MTD) of Daily Combination Fludarabine 30 mg/m^2 and Cytarabine 500 mg/m^2 Among 3 Dose Levels (Dose Level 1: 2 Days, Dose Level 2: 3 Days or Dose Level 3: 4 Days) — 90; 1500 mg/m^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oxaliplatin (Drug); Fludarabine (Drug); Cytarabine (Drug); Rituximab (Drug); Pegfilgrastim (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Total Tolerated Dose (MTD) of Daily Combination Fludarabine 30 mg/m^2 and Cytarabine 500 mg/m^2 Among 3 Dose Levels (Dose Level 1: 2 Days, Dose Level 2: 3 Days or Dose Level 3: 4 Days) |
90; 1500 | — |
| SECONDARY Overall Response: Number of Participants With Complete Remission, Nodular Partial Remission, and Partial Remission |
3; 27; 9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- All patients with histologically or cytologically confirmed Richter's transformation, prolymphocytic leukemia, aggressive, or relapsed/refractory B-cell chronic lymphocytic leukemia are eligible for this protocol.
- Patients must be 18 years of age or older.
- Patients must have a performance status of 0-2 (Zubrod scale).
- Patients must have adequate renal function (serum creatinine 50 mL/min). Patients with renal dysfunction due to organ infiltration by disease may be eligible after discussion with the principal investigator (PI) and consideration of appropriate dose adjustments.
- Patients must have adequate hepatic function (bilirubin 20,000, unless lower counts are due to disease involvement or autoimmune disorders.
Exclusion Criteria
- Untreated or uncontrolled life-threatening infection.
- Oxaliplatin, fludarabine, cytarabine or rituximab intolerance.
- Pregnancy or lactation.
- Chemotherapy and/or radiation therapy within 4 weeks.
- Medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
Data sourced from ClinicalTrials.gov (NCT00472849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.