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| Sponsored by: |
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 |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: filgrastim Drug: prednisone Drug: rituximab Drug: vincristine sulfate |
Phase III |
| MedlinePlus related topics: | Cancer Lymphoma |
| Drug Information available for: | Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Filgrastim Prednisone Vincristine sulfate Vincristine Rituximab |
| 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 | |||||
| Commissie Voor Klinisch Toegepast Onderzoek |
| Study Chair: | Pieter Sonneveld, MD, PhD | Daniel Den Hoed Cancer Center at Erasmus Medical Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000069122, CKTO-2000-10, HOVON-46NHL, EU-20130, HOVON-CKVO-2000-10 |
| First Received: | January 4, 2002 |
| Last Updated: | August 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00028717 |
| Health Authority: | United States: Federal Government |
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