Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Older Patients With Non-Hodgkin's Lymphoma

Not Recruiting

Trial ID: NCT00003150


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. It is not yet known if combination chemotherapy is more effective with or without rituximab for non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without rituximab in treating older patients who have non-Hodgkin's lymphoma.

Official Title

Phase III Trial of CHOP Versus CHOP and Chimeric Anti-CD20 Monoclonal Antibody (IDEC-C2B8) in Older Patients With Diffuse Mixed, Diffuse Large Cell and Immunoblastic Large Cell Histology Non-Hodgkin's Lymphoma

Stanford Investigator(s)


DISEASE CHARACTERISTICS: Histologically proven intermediate or high grade B-cell
non-Hodgkin's lymphoma (other than Burkitt's, non-Burkitt's, undifferentiated, or
lymphoblastic lymphoma) B-cell non-Hodgkin's lymphoma positive for CD19 and/or CD20 by
slide-based immunohistochemistry or flow cytometry No mantle cell or follicular lymphoma
Measurable disease, defined by at least one of the following: Physical examination
Radiographic findings of at least 2 dimensions Bidimensional measurable defect or mass
measuring at least 2 cm in diameter on radionuclide or CT scan Enlarged spleen extending at
least 2 cm below the costal margin provided that there is no other likely explanation
besides lymphomatous involvement Enlarged liver extending at least 5 cm below the costal
margin along with biopsy-proven lymphomatous hepatic involvement No history of transformed
lymphoma No known posttransplantation lymphoproliferative disorder No CNS involvement CALGB
patients 60-65 years of age must not be eligible for any other study of higher priority 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

PATIENT CHARACTERISTICS: Age: See Disease Characteristics 60 and over Performance status:
ECOG 0-3 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least
1,500/mm3 (unless due to lymphoma) Platelet count greater than 100,000/mm3 (unless due to
lymphoma) Hepatic: Bilirubin no greater than 3.0 mg/dL Renal: Creatinine less than 2.1
mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No active heart disease
including congestive heart failure, myocardial infarction within the past 3 months, or
symptomatic ventricular arrhythmia LVEF at least 45% if prior history of heart disease
exists Other: HIV negative No other malignancy within the past 5 years except squamous cell
or basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior biologic
response modifier therapy No prior immunotherapy No prior rituximab Chemotherapy: No prior
cytotoxic chemotherapy No concurrent dexrazoxane Endocrine therapy: Prior corticosteroids
allowed Radiotherapy: No prior radiotherapy No prior radioimmunotherapy Surgery: Not


biological: rituximab

drug: CHOP regimen

drug: vincristine sulfate

drug: cyclophosphamide

drug: doxorubicin hydrochloride

drug: prednisone

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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