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| Sponsors and Collaborators: |
Institute of Cancer Research, United Kingdom Australasian Leukaemia and Lymphoma Group (ALLG) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00053092 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy is more effective with or without rituximab in treating mantle cell lymphoma.
PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine and cyclophosphamide combined with rituximab to that of fludarabine and cyclophosphamide alone in treating patients who have mantle cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab Drug: cyclophosphamide Drug: fludarabine phosphate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| Official Title: | National Mantle Cell Lymphoma Trial - Phase II Randomized Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma |
| Estimated Enrollment: | 82 |
| Study Start Date: | October 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms:
NOTE: *In both arms, fludarabine and cyclophosphamide may be administered orally instead of IV.
Treatment repeats every 28 days for 2-8 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 56-82 patients (28-41 per treatment arm) 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 previously untreated mantle cell lymphoma requiring therapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| Australia, Victoria | |
| Peter MacCallum Cancer Centre | |
| East Melbourne, Victoria, Australia, 3002 | |
| United Kingdom, England | |
| Derriford Hospital | |
| Plymouth, England, United Kingdom, PL6 8DH | |
| Study Chair: | Simon Rule, MD | Derriford Hospital |
| Study Chair: | John Seymour, MD | Peter MacCallum Cancer Centre, Australia |
More Information
| Study ID Numbers: | CDR0000269136, NCRI-LY05, ALLG-LY05, EU-20230, NCRILG-LY05 |
| Study First Received: | January 27, 2003 |
| Last Updated: | May 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00053092 History of Changes |
| Health Authority: | United States: Federal Government |
|
contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma stage I mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma |
|
Antimetabolites Immunoproliferative Disorders Immunologic Factors Rituximab Lymphoma, Mantle-Cell Mantle Cell Lymphoma Cyclophosphamide Fludarabine monophosphate Immunosuppressive Agents |
Lymphatic Diseases Antineoplastic Agents, Alkylating Fludarabine Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Alkylating Agents Lymphoma |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Lymphoma, Mantle-Cell Physiological Effects of Drugs Cyclophosphamide Therapeutic Uses Lymphoma Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Rituximab Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Myeloablative Agonists Fludarabine Antineoplastic Agents, Alkylating Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Antirheumatic Agents |