SCHRIFT Trial

Trial Name

SCHRIFT - Short Chemo RadioImmunotherapy in Follicular Lymphoma Trial of ⁹⁰Y Ibritumomab tiuxetan (Zevalin) as therapy for first and second relapse in Follicular Lymphoma.

Description

A prospective phase II open label, non-randomised trial looking at short chemo-radioimmunotherapy in follicular lymphoma using Zevalin.

Objectives

Primary objective:

• To evaluate the response rates of short-duration R-Chemo followed by 90Y ibritumomab tiuxetan (Zevalin) in first or second relapse of patients with follicular non-Hodgkin's lymphoma (NHL).

Secondary objectives:

• To evaluate the duration of response of 3 cycles of R-CHOP followed by ⁹⁰Y ibritumomab tiuxetan (Zevalin).
• To evaluate the quality of response after 3 cycles of R-CHOP and following ⁹⁰Y ibritumomab tiuxetan (Zevalin) to determine the conversion rate from partial response to complete response.
• To evaluate the toxicity of ⁹⁰Y ibritumomab tiuxetan (Zevalin) when administered following 3 cycles of R-Chemo.

Design

This is a multi-centre, open labelled single arm, non-randomised prospective study to assess the preliminary safety and efficacy of abbreviated immunochemotherapy (3 cycles of CHOP-R) followed by 90Y ibritumomab tiuxetan (Zevalin) in patients with follicular NHL who have experienced a first or second relapse.

Status

Complete

Population

Sixty patients in first or second relapse of follicular NHL will be enrolled in the study. For patients who have received R-chemotherapy regimens, they must have relapsed 6 months or more after R-Chemotherapy. Patients who relapse within 6 months of R-chemotherapy or those who have primary refractory disease are excluded from the study .

Contact Details

All Trial enquiries should be addressed to ctu@soton.ac.uk