A Phase II Trial of R-CHOP Followed by Zevalin Radioimmunotherapy for Patients With Previously Untreated Stages I and II CD20+ Diffuse Large Cell Non-Hodgkin's Lymphoma
I. To evaluate the complete response rate (CR) and functional CR rate (CR or Cru/PR and PET
negative) in patients with previously untreated stage I (with at least 1 risk factor) or
stage II CD20+ diffuse large cell lymphoma who receive therapy with RCHOP followed by 90Y
I. To evaluate the time to treatment failure, duration of response, and overall survival in
these patients who receive therapy with R-CHOP followed by 90Y -Zevalin™.
II. To evaluate the toxicity of this therapy. III. To evaluate the toxicity of adding
involved field radiation therapy > 12 weeks after Zevalin™ for patients with CT+/PET+
I. To evaluate PET scans pre -and post - R-CHOP/Zevalin™ therapy.
Monoclonal antibody (MOAB) therapy/chemotherapy: Patients receive oral prednisone once daily
on days 1-5. Patients also receive rituximab IV over several hours followed by
cyclophosphamide IV, doxorubicin IV, and vincristine IV over 30-60 minutes on day 1.
Treatment repeats every 21 days for 2 courses in the absence of disease progression or
unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2
additional courses. Patients achieving a partial response, uncertain CR, or stable disease
receive 4 additional courses. Patients are evaluated 3 weeks after the last course of
therapy. Patients with progressive disease go off study.
MOAB therapy/radioimmunotherapy: Beginning no more than 9 weeks after the last course of
MOAB therapy and chemotherapy, patients receive rituximab IV on day 1 followed by indium In
111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive
rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
Radiotherapy: Patients with residual disease by CT scan or positron emission tomography
(PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 3 years, and then annually for 5 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response rate (CR/CRu)
Up to 10 years
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
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