Open-label study of GDC-0199 in follicular lymphoma patients
Research type
Research Study
Full title
A PHASE II, OPEN-LABEL STUDY EVALUATING THE SAFETY AND EFFICACY OF GDC-0199 (ABT- 199) PLUS BENDAMUSTINE PLUS RITUXIMAB (BR) IN COMPARISON WITH BR ALONE OR GDC-0199 PLUS RITUXIMAB (R) IN PATIENTS WITH RELAPSED AND REFRACTORY FOLLICULAR NON-HODGKIN’S LYMPHOMA
IRAS ID
156883
Contact name
Kirit Ardeshna
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2014-000576-26
Duration of Study in the UK
3 years, 0 months, 30 days
Research summary
The purpose of this study is to test the safety and efficacy (effect of the drug on the lymphoma) of two new treatments for follicular lymphoma in comparison to a standard treatment. One treatment is chemotherapy-free (arm A) and consists of the combination of the drug rituximab, which is standard treatment for lymphoma, and the new medicine GDC-0199. The other treatment (arm B) consists of the combination of a standard chemotherapy containing regimen of bendamustine and rituximab with the new medicine GDC-0199; this treatment (arm B) will be compared with the bendamustine and rituximab combination alone (arm C). Approximately 156 patients will take part in this study globally across 75 centres (about 6 centres in the UK). To participate, patients must be over 18 and have follicular lymphoma that got worse or had no response after initial or previous treatment. Patients would first need to go through some checks (screening) to see if they are eligible to take part. For patients who are eligible the study doctor will decide whether a chemotherapy-free or chemotherapy-containing regimen is the best treatment option for the patient (patients requiring a rapid reduction in tumour are likely to recommended for treatment with the chemotherapy-containing regimen). Patients receiving the chemotherapy-containing regimen will be randomly allocated to treatment arm B or C. Assessments for this study will include physical examinations, blood & urine samples, CT/PET scans, tumour biopsy, bone-marrow aspirate and biopsy. The study is sponsored by F. Hoffman-La Roche Ltd & AbbVie Inc.
REC name
London - Brent Research Ethics Committee
REC reference
14/LO/1406
Date of REC Opinion
4 Nov 2014
REC opinion
Further Information Favourable Opinion