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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Genzyme |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00800566 |
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.
Optional Procedures: You may be asked to have extra blood drawn for pharmacokinetic (PK) and pharmacodynamic (PD) testing. PK testing measures the amount of study drug in the body at different time points. PD testing is used to look at how the level of study drug in your body may affect the disease
Condition | Intervention | Phase |
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Leukemia Chronic Lymphocytic Leukemia |
Drug: Oral Clofarabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Study of Oral Clofarabine for the Treatment of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 36 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Oral Clofarabine
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Drug: Oral Clofarabine
The starting dose will be 1 mg orally daily x 21 days every 4 weeks +/- 4 days.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stefan F. Faderl, M.D. | 713/745-4613 | sfaderl@mdanderson.org |
United States, Texas | |
The University of Texas M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Stefan Faderl, M.D. 713-745-4613 sfaderl@mdanderson.org | |
Principal Investigator: Stefan Faderl, M.D. |
Principal Investigator: | Stefan F. Faderl, M.D. | M.D. Anderson Cancer Center |
Responsible Party: | The University of Texas M.D. Anderson Cancer Center ( Stefan Faderl, M.D./Associate Professor ) |
Study ID Numbers: | 2007-0905 |
Study First Received: | December 1, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00800566 |
Health Authority: | United States: Food and Drug Administration |
Clofarabine Leukemia Chronic Lymphocytic Leukemia |
Clofarabine Chronic lymphocytic leukemia Lymphatic Diseases Leukemia Leukemia, Lymphoid |
Immunoproliferative Disorders Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, chronic Lymphoproliferative Disorders Leukemia, B-Cell |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |