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Home > "C" Clinical Trials Conditions > Clofarabine in Chronic Lymphocytic Leukemia  Clofarabine in Chronic Lymphocytic Leukemia
Clofarabine in Chronic Lymphocytic Leukemia
For Condition: Leukemia, Lymphocytic, Chronic,Lymphoproliferative Disorders,Hematologic Neoplasms,Leukemia
Status: No longer recruiting
Sponsor(s): FDA Office of Orphan Products Development ,
Synopsis: This is a dose-escalation study to determine the maximum tolerated dose and toxic effects of clofarabine in patients with chronic lymphocytic leukemia and other acute leukemias. Clofarabine is a synthesized hybrid nucleoside analog, which is believed to possess the better qualities of fludarabine and chlorodeoxyadenosine, the 2 most active agents against lymphoproliferative disorders. Thus, it is hoped that this drug will be more active and less toxic than similar drugs.
Details: The first group of patients will be treated at the starting dose level of 2 mg/m2 over 1 hour daily for 5 days. Dosage escalation will be permitted in individual patients if no toxicity occurred during the preceding course. Subsequent dose escalations will be by 50% until Grade 2 toxicity, then by 35% until the maximum tolerated dose.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - Diagnosis of chronic lymphocytic leukemia - Diagnosis of other acute leukemia - At least 2 weeks since prior chemotherapy, immunotherapy, and/or radiotherapy - Recovered from toxic effects of prior therapy - Bilirubin no greater than 2 mg/dL - Creatinine no greater than 1.5 mg/dL Exclusion criteria: - Candidate for treatment of higher efficacy or priority - Pregnant or nursing
Total Enrollment: 100
Location and Contact Information:
Overall Study Official:
HagopKantarjian, Principal Investigator, University of Texas M.D. Anderson Cancer Center
University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: FD-R-1972-01; DM93-036; FD-R-001972-01
Study Start Date: February 1999
Record last reviewed: November 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028418
Other Hematologic Neoplasms Studies:
1. A Study of Motexafin Gadolinium for the Treatment of Chronic Lymphocytic Leukemia (CLL)
2. Study of ONTAK in patients with B-Cell Chronic Lymphocytic Leukemia (CLL)
3. A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
4. Safety and Efficacy of IDEC-152 in the Treatment of Chronic Lymphocytic Leukemia (CLL)
5. Clofarabine in Chronic Lymphocytic Leukemia
Related Studies:
Other Hematologic Neoplasms Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Clofarabine in Chronic Lymphocytic Leukemia
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