A randomized, open-label, multicenter phase 3 study of zanubrutinib (BGB-3111) plus anti-CD20 antibody versus lenalidomide plus rituximab in patients with relapsed/refractory follicular or marginal zone lymphoma
Aim of the study
The study will compare the efficacy, safety, tolerability and your quality of life in relation to the study treatment and the commonly used treatment.
Who can take part?
Relapsed/refractory follicular lymphoma or marginal zone lymphoma
Procedure
In our study, participants are randomly assigned to groups; this is called randomization. The use of this method is important in order to obtain reliable results. Each group receives a different treatment. There are 2 arms (groups) in our study:
If you have an FL, you will be randomly assigned to one of the two treatment arms - A or B - using a computer algorithm. The chance of being in one of the arms is 50:50 (equal chances), and neither you nor your investigator can choose the treatment arm you are assigned to. The medication in both arms is taken in cycles, with each cycle lasting 28 days.
- If you are randomized to Arm A, you will receive the following two drugs:
o Zanubrutinib, which, depending on your investigator's recommendation, can be administered either once daily (1 x
320 mg) or twice daily (2 x 160 mg) until the lymphoma is
reappears
AND
o Obinutuzumab administered intravenously in a hospital at a dose of 1000 mg
on days 1, 8 and 15 of cycle 1 and then on day 1 of each of cycles 2 to 6
is given.
- If you are randomized to arm B, you will receive the following two drugs:
o Lenalidomide, which is administered for up to 12 cycles at a dose of 20 mg daily on days
1 to 21 is taken in up to 12 cycles. It is possible that your investigator
decides to lower this dose depending on how well your kidneys are working,
AND
o Rituximab administered in a hospital on days 1, 8, 15 and 22 of cycle 1 and
is administered intravenously at a dose of 375 mg/m2 on day 1 of cycles 2 to 5.
Compensation
Original study name
A randomized, open-label, multicenter phase 3 study of zanubrutinib (BGB-3111) plus anti-CD20 antibody versus lenalidomide plus rituximab in patients with relapsed/refractory follicular or marginal zone lymphoma
BASEC number
2023-01259
Sponsors