- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00028418
Clofarabine in Chronic Lymphocytic Leukemia
Phase I Study of CL-F-ARA-A in Solid and Hematologic Malignancies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Completion date provided represents the completion date of the grant per OOPD records
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- University of Texas M. D. Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hagop M. Kantarjian, M.D., M.D. Anderson Cancer Center
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Hematologic Diseases
- Leukemia, B-Cell
- Hematologic Neoplasms
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Lymphoproliferative Disorders
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Clofarabine
Other Study ID Numbers
- FD-R-1972-01
- DM93-036; FD-R-001972-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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