![]() |
Home
Search
Study Topics
Glossary
|
Study 13 of 529 for search of: | Australia, Western Australia |
![]() |
Previous Study | Return to Search Results | Next Study |
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
Biogen Idec |
---|---|
Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00391066 |
This is a randomized (1:1), open-label, multicenter, active-controlled study in patients with previously treated CD23+ and CD20+ relapsed CLL. Patients will receive treatment with either lumiliximab in combination with FCR or FCR alone.
Condition | Intervention | Phase |
---|---|---|
Chronic Lymphocytic Leukemia |
Drug: FCR + Lumiliximab Drug: FCR |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open Label, Multicenter, Phase 2/3 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination With Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 900 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | December 2014 |
Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
FCR F (Fludarabine): 25 mg/m2 daily, every four weeks for 21 weeks C (Cyclophosphamide): 250 mg/m2 daily, every four weeks for 21 weeks R: (Rituximab): Day 1 50 mg/m2, Day 3 325 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks |
Drug: FCR
Dose, schedule, and duration specified in protocol
|
2: Experimental
FCR + Lumiliximab (L) L (Lumiliximab): Day 2 50 mg/m2, Day 4 450 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks. F (Fludarabine): 25 mg/m2 daily, every four weeks for 21 weeks C (Cyclophosphamide): 250 mg/m2 daily, every four weeks for 21 weeks R: (Rituximab): Day 1 50 mg/m2, Day 3 325 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks |
Drug: FCR + Lumiliximab
Dose, schedule, and duration specified in the protocol
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Biogen Idec | oncologyclinicaltrials@biogenidec.com |
Responsible Party: | Biogen Idec ( Biogen Idec MD ) |
Study ID Numbers: | 152CL201 |
Study First Received: | October 19, 2006 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00391066 |
Health Authority: | United States: Food and Drug Administration |
CLL CD23+/CD20+ B-cell CLL |
Chronic lymphocytic leukemia Leukemia, Lymphoid Immunoproliferative Disorders Rituximab Leukemia, B-cell, chronic Cyclophosphamide Fludarabine monophosphate |
Leukemia Lymphatic Diseases Leukemia, Lymphocytic, Chronic, B-Cell Fludarabine Leukemia, B-Cell Lymphoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |