International Phase II Study Evaluating the Association of CHOP-rituximab With Consolidation by Early Ibritumomab Tiuxetan-Y90 in Patients Aged 65 to 80 Years With CD20+ Large Cell Malignant Lymphoma and no Prior Therapy
- Determine event-free survival of patients with large B-cell lymphoma treated with
CHOP-R followed by consolidation therapy.
- Determine overall survival.
- Evaluate relapse-free survival for patients achieving complete or partial response.
- Determine the rate of disease progression.
- Determine response rate at the end of study therapy.
- Assess the toxicities of this regimen.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive the CHOP-R regimen comprising doxorubicin
hydrochloride IV, vincristine IV, cyclophosphamide IV, and rituximab IV on day 1 and
prednisone IV on days 1-5. Treatment repeats every 2 weeks for 2 courses.
Patients who achieve complete or partial response, as assessed by PET/CT scan, receive a
third course of induction therapy.
- Consolidation therapy: Patients receive rituximab IV on days -8 to 0 and yttrium Y 90
ibritumomab tiuxetan IV on day 0.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Frederec Peyrade, MD
Centre Antoine Lacassagne