Status:
TERMINATED
Study of Weekly Clofarabine for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Chronic Lymphocytic Leukemia
Leukemia
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Primary Objectives: 1. To determine the maximum tolerated dose (MTD) of clofarabine in Chronic Lymphocytic Leukemia (CLL). 2. To determine the toxicity profile of clofarabine in CLL. 3. To investigat...
Detailed Description
Clofarabine is a new chemotherapy drug that is designed to interfere with the growth and development of cancer cells. Before you can start treatment on the study, you will have what are called "scree...
Eligibility Criteria
Inclusion
- Patients with chronic lymphocytic leukemia (CLL), CLL/PLL (as defined by FAB), and PLL (B- and T-cell phenotypes) who have relapsed from or are refractory to at least one fludarabine-based regimen.
- Absolute neutrophil count (ANC) \>= 1 x 10(9)/L and platelet count \>= 50 x 10(9)/L
- Adequate liver function (total bilirubin \<= 1.5 x ULN, SGPT \<= 2.5 x ULN) and renal function (serum creatine \<= 1.5 x ULN).
- ECOG performance status \<= 2.
Exclusion
- Patients with NYHA \>= grade 3 heart disease as assessed by history and/or physical examination
- Pregnant or breastfeeding women or patients who are unwilling or unable to practice adequate contraception.
- Chemotherapy within 4 weeks of starting therapy, or concurrent anticancer therapy (chemotherapy, radiotherapy, or biologic therapy)
- Other malignancy within 3 years except in situ carcinoma
- Unwilling or unable to provide informed consent
- Hypersensitivity to nucleoside analogues
- Other significant medical condition that compromises safety, compliance or study conduct, including but not limited to uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within 6 months, ventricular arrhythmia, diabetes, active infection, pulmonary fibrosis, and chronic hepatitis
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00081887
Start Date
May 1 2004
End Date
June 1 2007
Last Update
August 1 2012
Active Locations (1)
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1
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030