Status:
COMPLETED
Oxaliplatin, Fludarabine, Cytarabine and Rituximab in Richter's Syndrome, Refractory CLL and PLL
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Sanofi
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 trans...
Detailed Description
Oxaliplatin, fludarabine, cytarabine and rituximab are anticancer drugs. Oxaliplatin is a platinum compound that has been shown to be effective in fighting other cancers. Oxaliplatin is a third genera...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed Richter's transformation, fludarabine-refractory chronic lymphocytic leukemia or prolymphocytic leukemia.
- 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 below or equal to 2mg/dL or creatinine clearance greater than 30mL/min), unless renal dysfunction is considered due to organ infiltration by disease.
- Patients must have adequate hepatic function (bilirubin less than or equal to 2.0 mg/dl; Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) less than or equal to 3 times the upper limit of normal (ULN) for the reference lab unless considered due to leukemia or congenital hemolytic disorder (for bilirubin).
- 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 in keeping with the policies of the hospital.
- Patients must have platelet counts greater or equal to 20,000, unless due to disease involvement, or autoimmune disorders.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00452374
Start Date
November 1 2004
End Date
January 1 2011
Last Update
November 2 2011
Active Locations (2)
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1
University of California-San Diego
La Jolla, California, United States, 92093
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115