Status:
COMPLETED
Oxaliplatin, Fludarabine, Cytarabine, and Rituximab in Patients With Richter's Transformation and Leukemias
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Sanofi
Conditions:
Richter's Transformation
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Cytarabine is designed to insert itself into DNA (the genetic material of cells) and stop the DNA from repairing itself. Oxaliplatin is designed to kill cancer cells by damaging their DNA. Fludarabi...
Eligibility Criteria
Inclusion
- 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
- 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 :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00472849
Start Date
May 1 2007
End Date
February 1 2012
Last Update
November 26 2013
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030