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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Sanofi-Aventis |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00472849 |
The goal of this clinical research study is to find the highest tolerable dose of fludarabine and cytarabine that can be given in combination with oxaliplatin and rituximab in the treatment of chronic lymphocytic leukemia (CLL), prolymphocytic leukemia, or Richter's transformation. Once the highest tolerable dose for this drug combination is found, the next goal of the study will be to find out if this combination therapy is effective in shrinking or slowing the growth of these diseases.
Condition | Intervention | Phase |
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Richter's Transformation Leukemia |
Drug: Oxaliplatin Drug: Fludarabine Drug: Cytarabine Drug: Rituximab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I-II Study of Oxaliplatin, Fludarabine, Cytarabine, and Rituximab in Patients With Richter's Transformation, Prolymphocytic Leukemia, Aggressive, Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 102 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2010 |
Arms | Assigned Interventions |
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1: Experimental
OFAR
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Drug: Oxaliplatin
Oxaliplatin 30 mg/m2/day, over approximately 2 hours, before fludarabine is started, on days 1-4.
Drug: Fludarabine
Fludarabine 30 mg/m2 daily I.V., over approximately 30 minutes, on days 2-3, 2-4, or 2-5 until maximum tolerated dose is reached.
Drug: Cytarabine
Cytarabine 500 mg/m2 daily I.V., 2-hour infusion starting 4 hours after first fludarabine dose is started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose is reached.
Drug: Rituximab
Rituximab 375 mg/m2 I.V. on day 3, course 1 (on day 1, subsequent courses).
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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: William G. Wierda, M.D., PhD | 713-745-0428 |
United States, Texas | |
The University of Texas M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: William G. Wierda, M.D., PhD 713-745-0428 | |
Principal Investigator: William G. Wierda, M.D., PhD |
Principal Investigator: | William G. Wierda, M.D., PhD | M.D. Anderson Cancer Center |
Responsible Party: | The University of Texas M. D. Anderson Cancer Center ( William Wierda, M.D./Associate Professor ) |
Study ID Numbers: | 2006-1026 |
Study First Received: | May 11, 2007 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00472849 |
Health Authority: | United States: Institutional Review Board |
OFAR 2 Oxaliplatin Fludarabine Cytarabine Ara-C Rituximab |
Richter's Transformation Prolymphocytic Leukemia B-Cell Chronic Lymphocytic Leukemia Leukemia CLL |
Chronic lymphocytic leukemia Richter syndrome Leukemia, Lymphoid Immunoproliferative Disorders Rituximab Leukemia, B-cell, chronic Fludarabine monophosphate Leukemia Lymphatic Diseases |
Oxaliplatin Leukemia, Prolymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Prolymphocytic leukemia Fludarabine Aggression Leukemia, B-Cell Lymphoproliferative Disorders Cytarabine |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents |
Physiological Effects of Drugs Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Antirheumatic Agents |