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| Sponsor: | Commissie Voor Klinisch Toegepast Onderzoek |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00028717 |
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 tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. It is not yet known if combination chemotherapy plus filgrastim is more effective with or without rituximab in treating non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy plus filgrastim with or without rituximab in treating older patients who have non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: filgrastim Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomized Phase III Study Of Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) With 2-Weekly CHOP Chemotherapy In Elderly Patients With Intermediate Or High-Risk Non-Hodgkin's Lymphoma |
| Estimated Enrollment: | 400 |
| Study Start Date: | February 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, WHO classification, and International Prognostic Index score. Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 5 years.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-Hodgkin's lymphoma (NHL)
Low- or high-intermediate or high-risk lymphoma of any of the following subtypes:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| Netherlands | |
| Academisch Medisch Centrum at University of Amsterdam | |
| Amsterdam, Netherlands, 1105 AZ | |
| Academisch Ziekenhuis Maastricht | |
| Maastricht, Netherlands, 6202 AZ | |
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | |
| Rotterdam, Netherlands, 3008 AE | |
| HagaZiekenhuis - Locatie Leyenburg | |
| 's-Gravenhage, Netherlands, 2545 CH | |
| Isala Klinieken - locatie Sophia | |
| Zwolle, Netherlands, 8000 GK | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 RC | |
| Vrije Universiteit Medisch Centrum | |
| Amsterdam, Netherlands, 1081HV | |
| Medisch Spectrum Twente | |
| Enschede, Netherlands, 7500 KA | |
| Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | |
| Amsterdam, Netherlands, 1066 CX | |
| Sint Antonius Ziekenhuis | |
| Nieuwegein, Netherlands, 3435 CM | |
| University Medical Center Groningen | |
| Groningen, Netherlands, 9713 EZ | |
| University Medical Center Utrecht | |
| Utrecht, Netherlands, 3584 CX | |
| Meander Medisch Centrum | |
| Amersfoort, Netherlands, 3816 CP | |
| Study Chair: | Pieter Sonneveld, MD, PhD | Daniel Den Hoed Cancer Center at Erasmus Medical Center |
More Information
| Study ID Numbers: | CDR0000069122, CKTO-2000-10, HOVON-46NHL, EU-20130, HOVON-CKVO-2000-10 |
| Study First Received: | January 4, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00028717 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I grade 3 follicular lymphoma stage I adult diffuse large cell lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse large cell lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse large cell lymphoma stage I mantle cell lymphoma contiguous stage II grade 3 follicular lymphoma |
contiguous stage II mantle cell lymphoma contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II mantle cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma |
|
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 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 Antineoplastic Agents, Alkylating |