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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 Leukemia Studies:
1. A Safety Evaluation of Xigris in Patients with Blood Cancer who Develop Severe Infection related to Bone Marrow Transplantation.
2. Clofarabine in Chronic Lymphocytic Leukemia
3. HLA-Mismatched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematological Malignancies
4. Sirolimus to Prevent GVHD after Stem Cell Transplant for Blood Cancers
5. Collection of Tissue Specimens from Patients with Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
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Clofarabine in Chronic Lymphocytic Leukemia
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