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| ID | Type | Description | Link |
|---|---|---|---|
| CKTO-2000-10 | |||
| HOVON-46NHL | |||
| EU-20130 | |||
| HOVON-CKVO-2000-10 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | |||
| rituximab | Biological | |||
| cyclophosphamide | Drug | |||
| doxorubicin hydrochloride | Drug | |||
| prednisone | Drug | |||
| vincristine sulfate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response | ||
| Overall survival | ||
| Disease-free interval |
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DISEASE CHARACTERISTICS:
Histologically confirmed non-Hodgkin's lymphoma (NHL)
Low- or high-intermediate or high-risk lymphoma of any of the following subtypes:
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:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Pieter Sonneveld, MD, PhD | Daniel Den Hoed Cancer Center at Erasmus Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meander Medisch Centrum | Amersfoort | 3816 CP | Netherlands | |||
| Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital |
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| Toxicity |
| Amsterdam |
| 1066 CX |
| Netherlands |
| Vrije Universiteit Medisch Centrum | Amsterdam | 1081HV | Netherlands |
| Academisch Medisch Centrum at University of Amsterdam | Amsterdam | 1105 AZ | Netherlands |
| Medisch Spectrum Twente | Enschede | 7500 KA | Netherlands |
| University Medical Center Groningen | Groningen | 9713 EZ | Netherlands |
| Leiden University Medical Center | Leiden | 2300 RC | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | 6202 AZ | Netherlands |
| Sint Antonius Ziekenhuis | Nieuwegein | 3435 CM | Netherlands |
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | Rotterdam | 3008 AE | Netherlands |
| HagaZiekenhuis - Locatie Leyenburg | The Hague | 2545 CH | Netherlands |
| University Medical Center Utrecht | Utrecht | 3584 CX | Netherlands |
| Isala Klinieken - locatie Sophia | Zwolle | 8000 GK | Netherlands |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D011241 | Prednisone |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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