2-Weekly CHOP Chemotherapy With Dose-Dense Rituximab for the Treatment of Patients Aged 61 to 80 Years With Aggressive CD-20 Positive B-Cell Lymphomas: A Phase-II/Pharmacokinetic Study (CHOP-R-ESC)
2-Weekly CHOP Chemotherapy With Dose-Dense Rituximab for the Treatment of Patients Aged 61 to 80 Years With Aggressive CD-20 Positive B-Cell Lymphomas: A Phase-II/Pharmacokinetic Study (CHOP-R-ESC)
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. All patients undergo the following treatment.
Patients are evaluated 2-4 weeks after completion of CHOP. Patients with initial bulky disease (i.e., diameter ≥ 7.5 cm) or extranodal involvement AND achieving complete remission (CR), unconfirmed CR (CRu), or partial remission undergo radiotherapy 5 days a week for 4 weeks. Patients who do not achieve CR or CRu 2 months after completion of radiotherapy proceed to salvage chemotherapy off study.
Patients are then stratified according to center, International Prognostic Index (1-2 vs 3-5), disease involvement (bulky vs extranodal vs bulky and/or extranodal), age (61-70 years old vs 71-80 years old), and gender. Patients are randomized to 1 of 2 treatment arms.
Some patients undergo blood sample collection periodically during and after treatment for pharmacokinetic studies.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then once a year therafter.
DISEASE CHARACTERISTICS:
Histological diagnosis of aggressive B-cell lymphoma
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:
PRIOR CONCURRENT THERAPY:
Ansbach, 91522, Germany
Cologne-Merheim, D-51109, Germany
Greifswald, 17487, Germany
Hamburg, D-20095, Germany
Koblenz, D-56068, Germany
Memmingen, 87700, Germany
Münster, D-48149, Germany
Stuttgart, D-70176, Germany