Rituximab and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Completed · Phase 2

Conditions studied: Lymphoma

In brief

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell non-Hodgkin's lymphoma.

Key facts

Study ID

NCT00274924

Run by

Eastern Cooperative Oncology Group

People needed

100

Starts

2006-09-26

Expected to finish

2019-03-01

Last updated by the study team

2023-06-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diffuse large B-cell non-Hodgkin's lymphoma
• Bulky stage II (bulk defined as any lesion ≥ 10 cm) or stage III or IV disease
• The following lymphoma types are excluded:
• Primary central nervous system lymphoma
• Transformed low-grade lymphoma (prior history of low-grade lymphoma or clear presence of low-grade lymphoma on histologic sections)
• Primary mediastinal B-cell lymphoma or testicular lymphoma (consolidative radiotherapy is usually indicated)
• Immunodeficiency-related lymphoma (i.e., after organ or bone marrow transplant)
• Measurable disease
• Patient must have at least one objective measurable disease site (i.e., measurable in at least 2 perpendicular parameters)
• Measurable disease in the liver is required if the liver is the only site of lymphoma involvement
• Abnormal positron emission tomography scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging
• Eastern Cooperative Oncology Group (ECOG) performance status 0-3
• For patients > 50 years of age, a normal ejection fraction by ECHO or Multigated Acquisition Scan (MUGA) is required within 6 weeks prior to registration
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count > 100,000/mm\^3
• Creatinine < 2.0 mg/dL
• Bilirubin < 2 mg/dL (may be up to 3.0 mg/dL if due to liver involvement by lymphoma)

You may not qualify if…

• Prior chemotherapy or radiation therapy for lymphoma
• Prior anthracyclines or platinum compounds used as systemic chemotherapy
• Prior radiation therapy to the mediastinum or to ≥ 25% of the bone marrow
• Concurrent pentostatin or trastuzumab (Herceptin®)
• Pregnant or nursing
• Prior malignancy within the past 5 years unless it was in situ OR was treated with curative intent AND the patient has remained relapse-free
• HIV positive

Where it is running

• Front Range Cancer Specialists — Fort Collins, Colorado, United States
• Baptist Cancer Institute - Jacksonville — Jacksonville, Florida, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Rush-Copley Cancer Care Center — Aurora, Illinois, United States
• St. Joseph Medical Center — Bloomington, Illinois, United States
• Graham Hospital — Canton, Illinois, United States
• Memorial Hospital — Carthage, Illinois, United States
• Robert H. Lurie Comprehensive Cancer Center at Northwestern University — Chicago, Illinois, United States
• Eureka Community Hospital — Eureka, Illinois, United States
• Evanston Northwestern Healthcare - Evanston Hospital — Evanston, Illinois, United States
• Galesburg Clinic, PC — Galesburg, Illinois, United States
• Galesburg Cottage Hospital — Galesburg, Illinois, United States
• Mason District Hospital — Havana, Illinois, United States
• Hinsdale Hematology Oncology Associates — Hinsdale, Illinois, United States
• Hopedale Medical Complex — Hopedale, Illinois, United States
• Joliet Oncology-Hematology Associates, Limited - West — Joliet, Illinois, United States
• McDonough District Hospital — Macomb, Illinois, United States
• Trinity Cancer Center at Trinity Medical Center - 7th Street Campus — Moline, Illinois, United States
• Study site — Moline, Illinois, United States
• BroMenn Regional Medical Center — Normal, Illinois, United States
• Community Cancer Center — Normal, Illinois, United States
• Community Hospital of Ottawa — Ottawa, Illinois, United States
• Oncology Hematology Associates of Central Illinois, PC - Ottawa — Ottawa, Illinois, United States
• Cancer Treatment Center at Pekin Hospital — Pekin, Illinois, United States
• Veterans Affairs Medical Center - Palo Alto — Palo Alto, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.