Study comparing rituximab plus zanubrutinib to rituximab monotherapy in SMZL
Research type
Research Study
Full title
Phase 3, interventional, multicentre, open-label, randomized study comparing rituximab plus zanubrutinib to rituximab monotherapy in previously untreated, symptomatic splenic marginal zone lymphoma (RITZ)
IRAS ID
1005891
Contact name
Anna La Fiura
Contact email
Sponsor organisation
International Extranodal Lymphoma Study Group (IELSG)
Eudract number
2023-503755-10
Clinicaltrials.gov Identifier
Research summary
Splenic marginal zone lymphoma (SMZL) is a type of cancer that affects small mature B-cells, which are a type of white blood cell.
One of the recommended treatments for SMZL is a medicine called rituximab.
The main goal of this study is to see if combining a medicine named zanubrutinib with rituximab is better than rituximab alone in treating people with SMZL who haven't received treatment before.
Additionally, the research will evaluate the safety of using zanubrutinib with rituximab compared to using rituximab alone.
Sixty trial participants are randomly assigned to two groups:
- Participants in Group A receive either zanubrutinib and rituximab
- Participants in Group B receive rituximab alone
“Randomly assigned” means that participants are put into the two groups purely by chance. Like flipping a coin to decide who goes where. Neither the doctors nor the participants choose which treatment they receive.
People in group A take zanubrutinib (a medicine taken orally twice a day) and rituximab an intravenous medicine (given on specific days) for one year.
Patients in group B take rituximab only for one year.
After one year of treatment,
- Participants who respond to treatment (complete response) discontinue it and enter “follow-up phase”.
- Participants who have a partial response (cancer improved not completely disappeared). continue treatment for 1 more year.
- Participants who do not respond to treatment discontinue therapy and enter the “follow-up phase”.
During the follow-up phase participants will return to the site for disease assessments every six months up to 3 years from treatment start.
The maximum trial duration for the participants is 3 years.Adult patients who voluntarily agree to participate after receiving appropriate explanations may participate in this trial. Only patients with SMZL and without any previous treatment for this disease can be enrolled. Adequate general health conditions are also required.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
24/YH/0049
Date of REC Opinion
19 Apr 2024
REC opinion
Further Information Favourable Opinion