Short Chemo Radiotherapy in Follicular Lymphoma Trial of 90Y Ibritumomab Tiuxetan (ZevalinTM) as Therapy for First and Second Relapse in Follicular Lymphoma
- To evaluate the response rates in patients with relapsed follicular non-Hodgkin
lymphoma treated with short-duration rituximab and combination chemotherapy (R-chemo)
followed by rituximab and yttrium Y 90 ibritumomab tiuxetan.
- To evaluate the duration of response in patients treated with this regimen.
- To evaluate the quality of response in order to determine the conversion rate from
partial response to complete response in patients treated with this regimen.
- To evaluate the toxicity of yttrium Y 90 ibritumomab tiuxetan when administered after 3
courses of R-chemo.
OUTLINE: This is a multicenter study.
- Chemoimmunotherapy (R-CHOP or R-CVP): Patients receive R-CHOP comprising rituximab IV,
cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral
prednisolone on days 1-5. Alternatively, patients who have already been exposed to
prior tolerance doses of anthracyclines receive R-CVP comprising rituximab IV,
cyclophosphamide IV, and vincristine IV on day 1 and oral prednisolone on days 1-5.
Treatment repeats every 3 weeks for up to 3 courses.
Patients with objective evidence of response on CT scan or those with < 25% bone marrow
involvement and no signs of bone marrow hypocellularity (< 15%) on bone marrow biopsy
proceed to radioimmunotherapy.
- Radioimmunotherapy: Four to 6 weeks after completion of R-CHOP or R-CVP, patients
receive rituximab IV followed no more than 4 hours later by yttrium Y 90 ibritumomab
tiuxetan IV over 10 minutes.
After completion of study therapy, patients are followed periodically for up to 5 years.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Overall response rate, including combined complete response and partial response
Christie Hospital NHS Foundation Trust