Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma
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ClinicalTrials.gov Identifier: NCT00028717 |
Recruitment Status : Unknown
Verified November 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 17, 2013
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma | Biological: filgrastim Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate | Phase 3 |
OBJECTIVES:
- Compare the efficacy of cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP), and filgrastim (G-CSF) with or without rituximab on event-free survival of elderly patients with intermediate or high-risk non-Hodgkin's lymphoma.
- Compare the complete remission rate, overall survival, and disease-free survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
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.
- Arm I: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5; and filgrastim (G-CSF) subcutaneously on days 1-14. Treatment repeats every 2 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive cyclophosphamide, doxorubicin, vincristine, prednisone, and G-CSF as in arm I. Patients also receive rituximab IV on day 3 of courses 1-2 and on day 1 of courses 3-6 for a total of 6 doses.
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | Randomized |
Primary Purpose: | Treatment |
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 |
Study Start Date : | February 2001 |

- Event-free survival
- Complete response
- Overall survival
- Disease-free interval
- Toxicity

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
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:
- Mantle cell lymphoma
- Follicular lymphoma (grade III)
- Diffuse large B-cell lymphoma
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- CD20-positive
- No suspected or documented CNS involvement by NHL NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
- 65 and over
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin less than 1.75 mg/dL*
- Transaminases less than 2.5 times normal* NOTE: * Unless due to NHL
Renal:
- Creatinine less than 1.7 mg/dL (unless due to NHL)
Cardiovascular:
- No severe cardiac dysfunction
- No New York Heart Association class II-IV heart disease
- LVEF at least 45%
Pulmonary:
- No uncontrolled asthma requiring steroid treatment
Other:
- HIV negative
- No intolerance to exogenous protein administration
- No active, uncontrolled infection
- No uncontrolled allergy requiring steroid treatment
- No other malignancy within the past 5 years except basal cell skin cancer or stage 0 cervical cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy for NHL
Chemotherapy:
- No prior chemotherapy for NHL
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy for NHL except local radiotherapy for potential organ dysfunction by localized lymphoma mass or infiltration
- Concurrent local radiotherapy for potential or actual organ dysfunction by localized lymphoma mass or infiltration allowed
Surgery:
- Not specified

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00028717
Netherlands | |
HagaZiekenhuis - Locatie Leyenburg | |
's-Gravenhage, Netherlands, 2545 CH | |
Meander Medisch Centrum | |
Amersfoort, Netherlands, 3816 CP | |
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | |
Amsterdam, Netherlands, 1066 CX | |
Vrije Universiteit Medisch Centrum | |
Amsterdam, Netherlands, 1081HV | |
Academisch Medisch Centrum at University of Amsterdam | |
Amsterdam, Netherlands, 1105 AZ | |
Medisch Spectrum Twente | |
Enschede, Netherlands, 7500 KA | |
University Medical Center Groningen | |
Groningen, Netherlands, 9713 EZ | |
Leiden University Medical Center | |
Leiden, Netherlands, 2300 RC | |
Academisch Ziekenhuis Maastricht | |
Maastricht, Netherlands, 6202 AZ | |
Sint Antonius Ziekenhuis | |
Nieuwegein, Netherlands, 3435 CM | |
Daniel Den Hoed Cancer Center at Erasmus Medical Center | |
Rotterdam, Netherlands, 3008 AE | |
University Medical Center Utrecht | |
Utrecht, Netherlands, 3584 CX | |
Isala Klinieken - locatie Sophia | |
Zwolle, Netherlands, 8000 GK |
Study Chair: | Pieter Sonneveld, MD, PhD | Daniel Den Hoed Cancer Center at Erasmus Medical Center |
ClinicalTrials.gov Identifier: | NCT00028717 History of Changes |
Other Study ID Numbers: |
CDR0000069122 CKTO-2000-10 HOVON-46NHL EU-20130 HOVON-CKVO-2000-10 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | September 17, 2013 |
Last Verified: | November 2007 |
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 |
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Prednisone Cyclophosphamide Rituximab Doxorubicin Vincristine Liposomal doxorubicin Lenograstim |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Immunological Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents |