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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: | NCT00726700 |
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, and vincristine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. 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. It is not yet known whether combination chemotherapy and pegfilgrastim is more effective when given with or without rituximab in treating non-Hodgkin lymphoma.
PURPOSE: This phase II trial is studying the side effects of giving pegfilgrastim and combination chemotherapy together with or without rituximab and to see how well it works in treating older patients with aggressive B-cell non-Hodgkin lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: pegfilgrastim Drug: prednisone Drug: rituximab Drug: vincristine sulfate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Randomized Phase II Study About the Application of Pegfilgrastim (Neulasta) at Day 2 or Day 4 Within the Treatment in Patients With Aggressive Non-Hodgkin's Lymphoma Aged 61 to 80 Years With 6 or 8 Cycles of Chemotherapy With CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) at 14-Day Intervals (CHOP-14), Both With or Without the Monoclonal Anti-CD20 Antibody Rituximab |
Estimated Enrollment: | 109 |
Study Start Date: | May 2004 |
Arms | Assigned Interventions |
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Arm I (without rituximab): Active Comparator
Patients receive pegfilgrastim subcutaneously (SC) on day 2 or 4 and CHOP comprising cyclophosphamide IV, doxorubicin IV, vincristine IV on day 1, and oral prednisone on days 1-5. Treatment repeats every 2 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity.
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Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: pegfilgrastim
Given subcutaneously
Drug: prednisone
Given orally
Drug: vincristine sulfate
Given IV
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Arm II (with rituximab): Experimental
Patients receive pegfilgrastim and CHOP for up to 6-8 courses as in arm I. They also receive rituximab (administered 2 hours before beginning CHOP) on day 1. Treatment with rituximab repeats every 2 weeks for up to 8 courses.
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Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: pegfilgrastim
Given subcutaneously
Drug: prednisone
Given orally
Drug: rituximab
Given IV
Drug: vincristine sulfate
Given IV
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OBJECTIVES:
OUTLINE: This is a multicenter study.
All patients receive prephase treatment comprising vincristine on day -6 and prednisone on days -6 to 0. Patients are then randomized to 1 of 2 treatment arms.
Patients with bulky disease or extranodal disease also undergo radiotherapy.
Ages Eligible for Study: | 61 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of CD20-positive B-cell non-Hodgkin lymphoma (NHL)
Aggressive disease, including any of the following B-cell NHL
Diffuse large B-cell lymphoma, including any of the following subtypes:
All risk group allowed
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000454473, DSHNHL-2003-2, EU-20534 |
Study First Received: | July 31, 2008 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00726700 |
Health Authority: | United States: Federal Government |
stage III grade 3 follicular lymphoma stage I adult lymphoblastic lymphoma stage III adult lymphoblastic lymphoma stage IV adult lymphoblastic lymphoma contiguous stage II adult lymphoblastic lymphoma noncontiguous stage II adult lymphoblastic lymphoma anaplastic large cell lymphoma stage III adult diffuse large cell lymphoma stage I adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma contiguous stage II adult diffuse large cell lymphoma contiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma stage III adult immunoblastic large cell lymphoma |
stage I adult immunoblastic large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage III adult Burkitt lymphoma stage IV adult Burkitt lymphoma stage III mantle cell lymphoma stage I mantle cell lymphoma contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma stage I adult Burkitt lymphoma contiguous stage II adult Burkitt lymphoma noncontiguous stage II adult Burkitt lymphoma stage III marginal zone lymphoma stage IV marginal zone lymphoma stage I marginal zone lymphoma contiguous stage II marginal zone lymphoma |
Prednisone Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Cyclophosphamide Lymphoma, large-cell, immunoblastic Lymphoma, B-Cell Lymphoma, large-cell Burkitt's lymphoma Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-Cell, Anaplastic Aggression Lymphoma Immunoglobulins Lymphoma, Large B-Cell, Diffuse |
Immunoproliferative Disorders Rituximab Vincristine Lymphoblastic lymphoma Mantle cell lymphoma Doxorubicin Lymphatic Diseases Antibodies Burkitt Lymphoma B-cell lymphomas Anaplastic large cell lymphoma Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Follicular lymphoma |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antimitotic Agents Antibiotics, Antineoplastic |
Hormones Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |