Zanubrutinib Plus Rituximab for Patients With Indolent Mantle Cell Lymphoma (ZEBRA)
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|ClinicalTrials.gov Identifier: NCT05635162|
Recruitment Status : Not yet recruiting
First Posted : December 2, 2022
Last Update Posted : December 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma||Drug: Zanubrutinib Drug: Rituximab||Phase 2|
This is a phase II, multicentre, randomised open label study to assess the safety and efficacy of zanubrutinib in combination with rituximab for previously untreated indolent MCL patients.
50 patients will be recruited from 15 UK centres over 30 months.
Enrolled patients will be randomised (1:1) to ongoing observation (control arm; arm A) or fixed-duration zanubrutinib-rituximab (experimental arm; arm B). Patients will discontinue zanubrutinib-rituximab after 6 cycles of therapy or sooner in the advent of unacceptable toxicity or any other reason.
All patients will be followed up for a minimum of 2 years after study enrolment. Patients in arm B who develop disease progression and require further therapy after the initial time-limited Zanu-R will receive standard of care therapy according to front line treatment available at that time.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised|
|Masking:||None (Open Label)|
|Official Title:||Zanubrutinib Plus Rituximab (Zanu -R) as Fixed Duration, Early Intervention Versus Observation for Patients With Indolent Mantle Cell Lymphoma: a Randomised Phase II Clinical Trial|
|Estimated Study Start Date :||March 1, 2023|
|Estimated Primary Completion Date :||March 31, 2027|
|Estimated Study Completion Date :||April 30, 2027|
No Intervention: Arm A: Control
Experimental: Arm B: Experimental
Time limited Zanubrutinib-R 6 x 28 day cycles
Zanubrutinib dose is 160 mg twice daily (BD) orally (PO) on days 1-28 of each 28-day cycle.
Rituximab 375 mg/m2 intravenous (IV)* on day 1 (+/-3 days) of each 28-day cycle
- Event free survival [ Time Frame: From date of randomisation until whichever comes first: occurrence of active disease, new MCL treatment or death (any cause) up to 60 months ]To determine the effect of fixed-duration Zanu-R on Event-free survival (EFS) compared to active observation
- Progression free survival [ Time Frame: Randomisation until disease progression up to 60 months ]To determine the effect of fixed-duration Zanu-R on Progression free survival (PFS) compared to active observation
- Overall survival [ Time Frame: Randomisation until date of death up to 60 months ]To determine the effect of fixed-duration Zanu-R on overall survival (OS) compared to active observation
- Time to next treatment [ Time Frame: Randomisation until date of initiation of subsequent treatment up to 60 months ]To determine the effect of fixed-duration Zanu-R on time to next treatment (TTNT) compared to active observation
- Overall response rate to Zanu-R [ Time Frame: From start of treatment until 24 weeks post administration of Zanu-R ]To determine the effect of fixed-duration Zanu-R on overall response rate (ORR) at the end of 6 cycles of treatment
- Overall response rate to re-treatment with covalent BTKi [ Time Frame: From the start of further treatment with a BTKi through to study completion, an average of 60 months ]To determine the ORR to re-treatment with covalent BTKi in experimental arm
- Safety and Toxicity [ Time Frame: From informed consent until 28 weeks post randomisation ]To assess the worst grade of each adverse event for each patient. Grades 1-2 and grades 3-5 will be compared between the arms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05635162
|Contact: ZEBRA Trial Coordinator||(+44) (0)firstname.lastname@example.org|
|Contact: Hayley Cartwright||(+44) (0)email@example.com|