Rituximab and Combination Chemotherapy in Treating Older Patients With Previously Untreated B-Cell Lymphoma

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, 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 older patients with previously untreated B-cell lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: German High-Grade Non-Hodgkin's Lymphoma Study Group
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histological diagnosis of aggressive B-cell lymphoma

• Previously untreated disease

• Stage I-IV disease

• CD20-positive disease

• Any International Prognostic Index (IPI) score

• No secondary lymphoma after prior chemotherapy or radiotherapy

• No primary CNS lymphoma

• No primary gastrointestinal (MALT) lymphoma

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy ≥ 3 months

• AST and ALT ≤ 3 times normal unless related to lymphoma

• Bilirubin ≤ 2 mg/dL unless related to lymphoma

• Creatinine ≤ 2 times normal unless related to lymphoma

• Fertile patients must use effective contraception

• No known allergic reactions against foreign proteins

• No active infections requiring systemically administered antibiotics or antiviral medications

• No noncompensated heart failure

• No dilatative cardiomyopathy

• No coronary heart disease with ST-segment depression in ECG

• No myocardial infarction during the past 6 months

• No chronic lung disease with hypoxemia

• No severe noncompensated hypertension

• No severe noncompensated diabetes mellitus

• No clinical signs of cerebral dysfunction

• No severe psychiatric disease

• No known HIV infection

• No active chronic hepatitis B or C infection

• No other concurrent diseases that exclude the administration of therapy as outlined by the study protocol

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• More than 12 weeks since prior clinical trial participation

• No prior participation in this study

• No prior therapy, including murine antibody, for this cancer

• No prior organ transplantation

• No concurrent response-adapted radiotherapy ("iceberg radiotherapy")

• No other concurrent anticancer chemotherapy or other study medication