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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00833534 |
RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether lenalidomide is more effective with or without rituximab in treating chronic lymphocytic leukemia or small lymphocytic lymphoma.
PURPOSE: This phase II trial is studying how well lenalidomide works when given with or without rituximab in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have undergone autologous or syngeneic stem cell transplant.
Condition | Intervention | Phase |
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Leukemia Lymphoma |
Biological: rituximab Drug: lenalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Consolidation Therapy With Lenalidomide (Revlimid®) With or Without Rituximab Followed by Maintenance Therapy With Revlimid® After Autologous/Syngeneic Transplant for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
Estimated Enrollment: | 20 |
Study Start Date: | February 2009 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group I (consolidation phase): Experimental
Patients receive oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
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Drug: lenalidomide
Given orally
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Group II (consolidation phase): Experimental
Patients receive lenalidomide as in group I. Patients also receive rituximab IV once on the day before the start of lenalidomide and then once between days 25-30, 50-55, and 75-80 for a total of 4 doses in the absence of disease progression or unacceptable toxicity.
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Biological: rituximab
Given IV
Drug: lenalidomide
Given orally
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OBJECTIVES:
Primary
OUTLINE:
Consolidation phase: Patients are assigned to 1 of 2 treatment groups.
Treatment repeats every 28 days for 18 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 28 days and then annually thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Has undergone autologous or syngeneic stem cell transplantation comprising high-dose therapy with peripheral blood stem cell rescue within the past 30-120 days
No progressive disease after transplantation
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: Leona A. Holmberg, MD, PhD 206-667-6447 lholmber@fhcrc.org |
Principal Investigator: | Leona A. Holmberg, MD, PhD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Leona A. Holmberg ) |
Study ID Numbers: | CDR0000633628, FHCRC-2150.00, IR-6846 |
Study First Received: | January 30, 2009 |
Last Updated: | March 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00833534 History of Changes |
Health Authority: | Unspecified |
stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia stage I small lymphocytic lymphoma |
stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma contiguous stage II small lymphocytic lymphoma noncontiguous stage II small lymphocytic lymphoma |
Leukemia, Lymphoid Immunoproliferative Disorders Immunologic Factors Rituximab Lenalidomide Leukemia Lymphatic Diseases |
Chronic Lymphocytic Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Antirheumatic Agents Leukemia, B-Cell Lymphoproliferative Disorders Leukemia, B-cell, Chronic Lymphoma |
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Antineoplastic Agents Rituximab Physiological Effects of Drugs Lenalidomide Pharmacologic Actions |
Leukemia Lymphatic Diseases Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Antirheumatic Agents Leukemia, B-Cell Lymphoproliferative Disorders Lymphoma |