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Sponsored by: |
German High-Grade Non-Hodgkin's Lymphoma Study Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00278421 |
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which schedule of rituximab and combination chemotherapy is more effective in treating non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | Randomized Study Comparing 4 and 6 Cycles of Chemotherapy With CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) at 21-Day Intervals, Both With 6 Cycles of Immunotherapy With the Monoclonal Anti-CD20-Positive B-Cell Lymphoma Aged 18-60 Years Having no Risk Factor (Age-Adjusted IPI=0) and No Large Tumor Mass (Diameter <7,5cm) [FLYER 6-6-6-4 Study] |
Estimated Enrollment: | 622 |
Study Start Date: | November 2005 |
Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
All patients are given the option of receiving a 1-week course of pretreatment therapy comprising vincristine IV once on day -6 and oral prednisone once daily on days -6 to 0.
After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 622 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma, including the following subtypes:
Diffuse B-cell lymphoma, including diffuse large cell lymphoma with any of the following variants:
No bulky disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Michael G.M. Pfreundschuh, MD | Universitaetsklinikum des Saarlandes |
Study ID Numbers: | CDR0000459685, DSHNHL-2004-2, EU-205110, EUDRACT-2005-00521738, DSHNHL-FLYER-6664 |
Study First Received: | January 16, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00278421 History of Changes |
Health Authority: | Unspecified |
contiguous stage II grade 3 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma stage I grade 3 follicular lymphoma contiguous stage II adult diffuse large cell lymphoma contiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma stage I adult diffuse large cell lymphoma stage I adult diffuse mixed cell lymphoma nodal marginal zone B-cell lymphoma anaplastic large cell lymphoma contiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma stage I adult immunoblastic large cell lymphoma contiguous stage II adult Burkitt lymphoma |
contiguous stage II mantle cell lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II mantle cell lymphoma stage I adult Burkitt lymphoma stage I mantle cell lymphoma contiguous stage II marginal zone lymphoma noncontiguous stage II marginal zone lymphoma stage I marginal zone lymphoma stage III marginal zone lymphoma stage IV marginal zone lymphoma stage III adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult immunoblastic large cell lymphoma stage III grade 3 follicular lymphoma |
Anti-Inflammatory Agents Prednisone Immunologic Factors Hormone Antagonists Lymphoma, Mantle-Cell Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Mantle Cell Lymphoma Cyclophosphamide Hormones Follicular Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse |
Anti-Bacterial Agents Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-cell Alkylating Agents Lymphoma Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Antineoplastic Agents, Hormonal Rituximab Vincristine Antimitotic Agents Glucocorticoids Immunosuppressive Agents Doxorubicin |
Anti-Inflammatory Agents Prednisone Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Antibiotics, Antineoplastic Hormones Therapeutic Uses Lymphoma, Large-Cell, Immunoblastic Lymphoma Alkylating Agents Immunoproliferative Disorders |
Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Rituximab Mitosis Modulators Vincristine Antimitotic Agents Glucocorticoids Immunosuppressive Agents Doxorubicin Pharmacologic Actions Lymphatic Diseases Neoplasms Tubulin Modulators Myeloablative Agonists |