A Phase II Study of R-CHOP and Ibritumomab Tiuxetan (Zevalin) for Elderly Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
- Determine the progression-free and overall survival of patients age 60 and over with
previously untreated diffuse large B-cell lymphoma treated with rituximab,
cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) combined with
yttrium Y 90 ibritumomab tiuxetan.
- Determine the incidence of adverse experiences, hematologic toxicity (WBC, hemoglobin,
and platelet nadirs; and transfusion requirements), cardiac toxicity (incidence of left
ventricular dysfunction and cardiomyopathy by echocardiography), and the development of
human antimouse antibody/human anti-chimeric antibody in patients treated with this
- Determine the predictive value of detecting minimal residual disease by molecular
techniques for future relapse/recurrence in patients treated with this regimen.
- Determine the response rate of patients treated with this regimen.
- Determine the red blood cell transfusion requirements, change in hemoglobin from
baseline, and incidence of anemia with prophylactic darbepoetin alfa support in
patients treated with this regimen.
- Determine the conversion rate to complete remission in patients treated with
ibritumomab tiuxetan who achieve a partial remission post-R-CHOP.
- Determine the effect of darbepoetin alfa on the quality of life of these patients.
OUTLINE: This is an open-label, nonrandomized study.
- Chemotherapy: Patients receive rituximab IV over 2-5 hours, cyclophosphamide IV,
doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5 or 2-6; and
filgrastim (G-CSF) subcutaneously (SC) on days 7-15. Patients also receive darbepoetin
alfa SC on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of
disease progression or unacceptable toxicity.
- Radioimmunotherapy: Patients receive rituximab IV over 3-5 hours and indium In 111
ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0.
Patients undergo gamma camera imaging at 2-24 hours and 48-72 hours after the injection of
IDEC-In2B8 to observe the flow of ibritumomab tiuxetan. If the flow is deemed safe, then
patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7.
Quality of life is assessed at baseline, before course 5 of chemotherapy, before
radioimmunotherapy, and at 3 months.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Paul A. Hamlin, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|