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
PRIMARY OBJECTIVES:
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
-Zevalin™.
SECONDARY OBJECTIVES:
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+
residual masses.
TERTIARY OBJECTIVES:
I. To evaluate PET scans pre -and post - R-CHOP/Zevalin™ therapy.
OUTLINE:
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
radiotherapy.
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response rate (CR/CRu)
Up to 10 years
No
Thomas Witzig
Principal Investigator
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
NCI-2012-02957
NCT00088881
December 2004
Name | Location |
---|---|
Eastern Cooperative Oncology Group | Boston, Massachusetts 02215 |