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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00238238 |
Purpose
RATIONALE: 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. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide may also stop the growth of non-Hodgkin's lymphoma by blocking blood flow to the cancer. Giving rituximab together with lenalidomide may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying how well rituximab and/or lenalidomide work in treating patients with follicular non-Hodgkin's lymphoma that is not refractory to rituximab.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab Drug: lenalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Trial of Rituximab Versus Lenalidomide (REVLIMID™, Cc-5013) (IND#73034) Versus Rituximab + Lenalidomide in Recurrent Follicular Non-Hodgkin Lymphoma (NHL) That is Not Rituximab-Refractory |
| Estimated Enrollment: | 180 |
| Study Start Date: | March 2006 |
| Estimated Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I (closed to accrual as of 9/15/07)
Patients receive rituximab IV on days 1, 8, 15, and 22.
|
Biological: rituximab
Given IV
|
|
Experimental: Arm II
Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
Drug: lenalidomide
Given orally
|
|
Experimental: Arm III
Patients receive lenalidomide as in arm II. Patients also receive rituximab IV on days 8, 15, and 22 of course 1 and day 1 of course 2 of lenalidomide.
|
Biological: rituximab
Given IV
Drug: lenalidomide
Given orally
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
After completion of study treatment, patients are followed for up to 10 years from study entry.
PROJECTED ACCRUAL: A total of 180 patients (90 for arm I [closed to accrual as of 9/15/07], 45 each for arms II and III) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically* confirmed follicular non-Hodgkin's lymphoma
Measurable disease > 1 cm
No non-measurable disease only, including any of the following:
Must have been treated with rituximab either alone or in combination with chemotherapy
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
No "currently active" secondary malignancy (e.g., Waldenstrom's macroglobulinemia) except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent hormonal therapy except for the following:
No concurrent dexamethasone or other steroids as antiemetics
Radiotherapy
Other
Contacts and Locations
Show 79 Study Locations| Study Chair: | John P. Leonard, MD | Weill Medical College of Cornell University |
More Information
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00238238 History of Changes |
| Other Study ID Numbers: | CDR0000442872, CALGB-50401 |
| Study First Received: | October 12, 2005 |
| Last Updated: | March 26, 2011 |
| Health Authority: | Unspecified |
|
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma |
|
Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Rituximab Thalidomide Lenalidomide Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents Immunosuppressive Agents Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |