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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Sanofi
• Treatments: Cytarabine; Fludarabine; Fludarabine phosphate; Oxaliplatin; Rituximab; Vidarabine

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 <= 2 mg/dL or creatinine clearance > 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 <= 2 mg/dl; aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) < 2.5 * the upper limit of normal (ULN) for the reference lab unless due to leukemia or congenital hemolytic disorder [for bilirubin]). Patients with hepatic dysfunction due to organ infiltration by disease may be eligible after discussion with the PI and consideration of appropriate dose adjustments.

• Female patients of childbearing potential (including those < 1 year post-menopausal) and male patients must agree to use contraception.

• Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.

• Patients must have platelet counts > 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.