OASIS-II
Research type
Research Study
Full title
A randomized phase II trial evaluating Ibrutinib plus CD20 Ab and Ibrutinib-Venetoclax plus CD20 Ab in patients with untreated mantle cell lymphoma
IRAS ID
1004038
Contact name
Pascal Bilbault
Contact email
Sponsor organisation
Lymphoma Academic Research Organisation
Eudract number
2020-004910-37
Clinicaltrials.gov Identifier
Research summary
Mantle cell lymphoma (MCL) is a rare but aggressive form of non hodgkin's lymphoma. The treatment of choice for MCL patients is based on high dose chemotherapy. This can be a very toxic treatment and is not tolerated by all patients, and age and other medical problems make chemotherapy very difficult to give successfully in many cases.
New non-chemotherapy treatment approaches may offer excellent outcomes with significantly less toxic side effects, and are currently being investigated as treatment for newly diagnosed MCL. Ibrutinib alone or in combination with CD20 antibody (for example rituximab) have shown high level of efficacy in relapsed and refractory (R/R) MCL and is widely used in this setting.
The combination of ibrutinib, venetoclax and antiCD20 antibody has been shown to be safe and highly effective in a previous study (called the OASIS study).
The aim of this study is to compare two non-chemotherapy approaches (ibrutinib and rituximab versus ibrutinib, venetoclax and rituximab) in the treatment of previously untreated MCL.
This is a multicentre, open label, randomised phase II study in untreated MCL patients conducted in the UK, France and Belgium. There will be an interim analysis after 46 patients. The primary endpoint of the study is response at 6 months. We are also going to compare overall survival, progression free survival, and safety and tolerability of the drugs.
Both treatment arms will have 2 years' treatment with ibrutinib+/-venetoclax.
We will recruit patients from 15 sites in the UK.REC name
London - Chelsea Research Ethics Committee
REC reference
22/LO/0118
Date of REC Opinion
21 Mar 2022
REC opinion
Further Information Favourable Opinion