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Sponsors and Collaborators: |
Sarah Cannon Research Institute SCRI Oncology Research Consortium Celgene Corporation Genentech |
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Information provided by: | Sarah Cannon Research Institute |
ClinicalTrials.gov Identifier: | NCT00536341 |
This phase I/II trial will combine fludarabine, rituximab, and lenalidomide in untreated or minimally treated (Phase I only) CLL patients, employing fixed doses of fludarabine and rituximab, using a schedule similar to that examined by the investigators at MD Anderson. Given that the optimal dose and schedule is not currently known, this trial will perform a phase I component followed by a phase II examination to further explore this regimen's activity.
Condition | Intervention | Phase |
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Chronic Lymphocytic Leukemia |
Drug: lenalidomide, fludarabine and rituximab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of Fludarabine, Rituximab, and Lenalidomide in Minimally Treated and Untreated Patients With Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 40 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Phase I Non-Stratified, dose-escalation: >=3 patients per dose level. Safety and tolerability will be evaluated every 2 weeks during the active treatment. Doses of lenalidomide will be escalated, while the fludarabine and rituximab doses remain fixed.
Phase II The Phase II regimen will be chosen following a review of the Phase I data. Following selection of the Phase II schedule, 16 treatment naive patients will be enrolled and treated with the Phase II regimen every 28 days for up to 6 courses. For those patients achieving a CR after 3 cycles, one additional cycle of treatment will be administered beyond CR confirmation.
Primary (Phase I) Portion:
Primary (Phase II) Portion:
Secondary (Phase II) Portion:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ian W. Flinn, M.D. | (615) 329-7274 | iflinn@tnonc.com |
Contact: Trials Info | (615) 329-7274 | trialsinfo@scresearch.net |
United States, Tennessee | |
Tennessee Oncology, PLLC | Recruiting |
Nashville, Tennessee, United States, 37023 |
Study Chair: | Ian W. Flinn, M.D. | SCRI Oncology Research Consortium |
Responsible Party: | SCRI Oncology Research Consortium ( Ian W. Flinn, M.D. ) |
Study ID Numbers: | SCRI CLL 02 |
Study First Received: | September 24, 2007 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00536341 |
Health Authority: | United States: Food and Drug Administration |
Chronic Lymphocytic Leukemia untreated minimally treated |
fludarabine rituximab lenalidomide |
Chronic lymphocytic leukemia Leukemia, Lymphoid Immunoproliferative Disorders Rituximab Leukemia, B-cell, chronic Lenalidomide Fludarabine monophosphate |
Leukemia Lymphatic Diseases Leukemia, Lymphocytic, Chronic, B-Cell Fludarabine Leukemia, B-Cell Lymphoproliferative Disorders |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Antirheumatic Agents |