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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Eastern Cooperative Oncology Group NCIC Clinical Trials Group Southwest Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00602459 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Giving fludarabine and rituximab together with lenalidomide or cyclophosphamide may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying fludarabine and rituximab to compare how well they work with or without lenalidomide or cyclophosphamide in treating patients with symptomatic chronic lymphocytic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: rituximab Drug: cyclophosphamide Drug: fludarabine phosphate Drug: lenalidomide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Genetic Risk-Stratified, Randomized Phase II Study of Four Fludarabine/Antibody Combinations for Patients With Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia |
| Estimated Enrollment: | 405 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients receive rituximab IV on days 1, 3, and 5 of course 1 and on day 1 of all subsequent courses. Patients also receive fludarabine phosphate IV over 30 minutes or orally on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression.
|
Biological: rituximab
given IV
Drug: fludarabine phosphate
given IV
|
|
Experimental: Arm II
Patients undergo RI therapy as in arm I. Patients with a complete or partial response or stable disease proceed to RC therapy beginning approximately 4 months after completion of RI, comprising oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 3-6 courses in the absence of disease progression.
|
Biological: rituximab
given IV
Drug: fludarabine phosphate
given IV
Drug: lenalidomide
given orally
|
|
Experimental: Arm III
Patients receive rituximab IV on days 1 and 3 of course 1 and on day 1 of all subsequent courses. Patients also receive fludarabine phosphate IV over 30 minutes or orally followed by cyclophosphamide IV over 30 minutes on days 1-3. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression.
|
Biological: rituximab
given IV
Drug: cyclophosphamide
given IV
Drug: fludarabine phosphate
given IV
|
|
Experimental: Arm IV
Patients undergo the first course of RI therapy as in arm I or II, followed by rituximab IV on day 1 of all subsequent courses, and fludarabine IV over 30 minutes and cyclophosphamide IV over 30 minutes on days 1-3. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression. Beginning approximately 4 months after completion of RI therapy, patients receive RC therapy comprising oral lenalidomide as in arm II.
|
Biological: rituximab
given IV
Drug: cyclophosphamide
given IV
Drug: fludarabine phosphate
given IV
Drug: lenalidomide
given orally
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria:
Absolute lymphocytosis > 5,000/μL
Bone marrow aspirate smear must show > 30% of all nucleated cells as being lymphoid OR bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL
Lymphocyte phenotype must reveal predominant B-cell monoclonal population sharing a B-cell marker (i.e., CD19, CD20, or CD23) with the CD5 antigen, in the absence of other pan-T-cell markers
B-cells must be monoclonal with regard to expression of either kappa or lambda light chains and have surface immunoglobulin expression of low density
Must have symptomatic, active disease and meet 1 of the following risk criteria according to the modified three-stage Rai staging system:
Intermediate-risk disease (i.e., Rai stage I or II) with evidence of active disease as demonstrated by at least one of the following criteria:
PATIENT CHARACTERISTICS:
Patients with HIV infection may be eligible provided they meet the following criteria:
PRIOR CONCURRENT THERAPY:
Contacts and Locations
Show 281 Study Locations| Study Chair: | John C. Byrd, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
| Study Chair: | Mitchell R. Smith, MD, PhD | Fox Chase Cancer Center |
| Study Chair: | Stephen Couban, MD | Cancer Care Nova Scotia |
| Study Chair: | John E. Godwin, MD, MS | Simmons Cooper Cancer Institute |
More Information
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00602459 History of Changes |
| Other Study ID Numbers: | CDR0000584205, CALGB-10404, CAN-NCIC-CL3, ECOG-10404, NCIC-CTG-C10404, SWOG-C10404 |
| Study First Received: | January 23, 2008 |
| Last Updated: | April 6, 2011 |
| Health Authority: | Unspecified |
|
B-cell chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia |
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Fludarabine monophosphate Thalidomide Rituximab Fludarabine |
Lenalidomide Vidarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites |