Zanubrutinib-based Induction and Maintenance Therapy in Young and Fit Patients With Untreated Mantle Cell Lymphoma
Status:
Recruiting
Trial end date:
2026-02-28
Target enrollment:
Participant gender:
Summary
This is a prospective, single-center, single-arm, phase II study of Zanubrutinib-based
induction followed by ASCT and Zanubrutinib maintenance (2 years) or followed directly by
Zanubrutinib maintenance without ASCT in young and fit patients with untreated MCL.
There will be an initial safety run-in phase of 6 patients which will be closely monitored
for the observed toxicities during cycle1 in， induction therapy. After completion of safety
run-in phase, the investigator will assessed and decided whether to continue the trial as
planned. If no unexpected toxicity has been observed, study will expand the sample size to
further assess efficacy and safety.
Total around 47 patients aged 18-65 years with previously untreated, Ann Arbor stage II-IV,
histologically proven MCL will be enrolled to receive alternating 3 cycles R-CHOP +
Zanubrutinib /3 cycles R-DHAOx induction. Totally 6 cycles in induction and every 21 days per
cycle. Due to lack of published data about BTKi in combination with R-DHAOx, Zanubrutinib is
only applied in cycle 1,3,5(R-CHOP), 160mg BID, d1-21, and not in combination with R-DHAOx
Patients who achieve remission (≥PR) will be allowed to proceed to ASCT or maintenance.
Whether ASCT or not depends on investigator's evaluation and discretion. In patients who do
not achieve a remission at end of induction (treatment failure), no study specific treatment
is defined; rather, the further salvage treatment is upon the discretion of investigators.
Patients remain in study for progression and survival follow-up.
Patients will receive Zanubrutinib maintenance for two years in case of remission at ASCT
assessment or end of induction assessment. Zanubrutinib is applied oral 160mg BID,
continuously for 2 year or until progressive disease, unacceptable toxicity or death,
whichever comes first.
The primary analysis will be performed after last-patient completes induction treatment.