Lymphoma, Non-Hodgkin Clinical Trial
Official title:
Phase II Study for Use of Oral Fludarabine Plus Cyclophosphamide and Rituximab Followed by Zevalin as Front-Line Treatment for Non-Follicular Indolent Lymphomas.
Pilot multicentre, open label study with the aim to evaluate antitumor activity in term of
the sum of complete and partial response (O.R.R.) of chemotherapy (cyclophosphamide and
fludarabine) and rituximab, followed by zevalin radioimmunotherapy and response duration
(Time to relapse or progression)and to evaluate the safety of the treatment as acute and
late toxicity.
Secondary objective is to evaluate the overall survival (OS) and the event-free survival
(EFS).
Test medication:
- Yttrium-90 (90Y) ibritumomab tiuxetan 0.4 mCi/kg is delivered to patient achieving at
least a partial remission (PR) after chemotherapy as a single dose for patients with
baseline platelet counts>150x10^9/L or 0.3 mCi/kg for patients with baseline platelet
counts of 100 to 149x10^9/L. Rituximab 250mg/sqm is given prior to therapeutic
radiolabeled antibodies.
- Standard dose chemotherapy consisting of cyclophosphamide, fludarabine and rituximab
given every 28 days up to the best response (maximum 6 courses).
- A prophylaxis for pneumocystis carinii as well as for herpes zoster are needed during
treatment.
Main parameters of activity: activity of Yttrium-90 (90Y) ibritumomab tiuxetan after
cyclophosphamide, fludarabine and rituximab combination.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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