Comparison study between two treatments (zanubrutinib + rituximab and rituximab alone) for splenic marginal zone lymphoma in previously untreated individuals.

Summary description of the study

The study compares treatment with zanubrutinib + rituximab or with rituximab alone in individuals with SMZL who have never received treatment before. It is an interventional study (involves a specific treatment), phase III (to verify if a new treatment is better than one in use), multicenter (conducted at multiple sites), open-label (participants and doctors know which treatment is being administered), randomized (participants are randomly assigned to receive one of the 2 studied treatments). The main objective of the study is to verify if the combination of the 2 drugs is more effective. Doctors measure the time it takes for cancer to progress (progression-free survival), the number of people responding to treatment (overall response rate), the duration of response, and the duration of survival (overall survival). The safety of using zanubrutinib + rituximab compared to using rituximab alone is also evaluated. Doctors also analyze: 1. how many patients have a complete remission (i.e., the tumor completely disappears) at 12 and 24 months, 2. the best outcome achieved by a patient in terms of tumor reduction or disappearance, 3. time to next treatment (the period of time patients spend without requiring another treatment after the study), 4. how long the treatment works without the tumor worsening (duration of response), and 5. the lifespan of individuals (overall survival). Patients will be asked to complete questionnaires about their quality of life during the study.

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Intervention under investigation

This study evaluates whether the administration of zanubrutinib with rituximab is better than the administration of rituximab alone for individuals with a type of tumor called SMZL who have not been treated previously.

About 60 people will be randomly assigned to each of the two treatment groups: patients receive zanubrutinib and rituximab (Group A) or rituximab alone (Group B). The study includes three phases: screening, treatment, and follow-ups after treatment. Patients who complete treatment or discontinue for any reason, as well as patients whose tumor worsens during the study, discontinue treatment and enter the follow-up phase where visits continue without the treatment planned by the study.

(BASEC)

Disease under investigation

Splenic marginal zone lymphoma (SMZL). SMZL is a type of cancer that affects mature small B lymphocytes, which are a type of white blood cell.

(BASEC)

Sponsor

International Extranodal Lymphoma Study Group (IELSG)

(BASEC)

Name of the authorising ethics committee (for multicentre studies, only the lead committee)

Ethics Committee Ticino

(BASEC)

Date of authorisation

15.02.2024

(BASEC)

Results of the trial