Status:
WITHDRAWN
Oral Clofarabine in Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Leukemia
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to find the highest tolerable dose of clofarabine when given to patients with CLL. The safety of this drug will also be studied.
Detailed Description
The Study Drug: Clofarabine is designed to interfere with the growth and development of cancer cells. Screening Tests: Before you can begin taking the study drug, you will have "screening tests" to...
Eligibility Criteria
Inclusion
- Patients with chronic lymphocytic leukemia (CLL), CLL/PLL (as defined by FAB \[French-American-British Classification\]), small lymphocytic lymphoma (SLL) and prolymphocytic leukemia (PLL) who have relapsed from or are refractory to at least one fludarabine-based regimen and no greater than 2 regimens.
- Absolute neutrophil count (ANC) \>= 1 x 109/L and platelet count \>= 50 x 109/L.
- Adequate organ function as indicated by the following laboratory values: serum creatinine \</= 1 mg/dL; if serum creatinine \> 1 mg/dL, then the estimated glomerular filtration rate (GFR) must be \> 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation; serum bilirubin \</= 1.5 mg/dL x ULN; aspartate transaminase (AST)or alanine transaminase (ALT) \</= 2.5 x ULN; alkaline phosphatase \</= 2.5 x ULN.
- ECOG performance status \<= 2.
- Age \>/= 18 years.
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. Positive pregnancy test for women of child bearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization).
- 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.
- Known hypersensitivity to nucleoside analogues.
- Any other significant medical condition that compromises safety, compliance or study conduct, including but not limited to uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, ventricular arrhythmia, active infection, and known hepatitis.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00800566
Start Date
November 1 2008
End Date
April 1 2009
Last Update
August 1 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030