This is a phase II, open-label, multicentre study of Zanubrutinib-containing regimens in patients with newly diagnosed mantle cell lymphoma.
This study is a prospective, multicenter, investigator-initiated clinical trial to evaluate the efficacy and safety of zanubrutinib-containing regimens in the treatment of newly diagnosed elderly or young patients with high risk MCL, aiming to find a more optimal treatment regimen for elderly or young patients with high risk MCL to improve the efficacy, survival time and quality of life of patients. In elderly patients arm:patients start with the induction therapy of zanubrutinib combined with obinutuzumab for 1 year and then entered the maintenance therapy of zanubrutinib orally until intolerable toxicity or disease progression In young patients with high risk arm:patiens \<65 years,and meet one or more of the following risk factors: TP53 mutation, blastoid/pleomorphic type, high sMIPI score. patients start with 6 cycles of induction therapy with zanubrutinib combined with R-BAC regimen, and the patients who achieve CR/PR and meet the transplantation criteria will receive ASCT consolidationand, then received maintenance therapy with zanubrutinib. otherwise, Patients who is ineligible for transplantation,will take zanubrutinib orally until intolerable toxicity or disease progression.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Zanubrutinib, 160mg PO BID. C1D17 continuously for 1 year or until progressive disease; Obinutuzumab :Obinutuzumab will be administered 1,000 mg intravenously on days 1, 8, and 15 of cycle 1, then 1,000 mg on day 1 of cycles 2 to 6, then 1,000 mg every 8 weeks,up to 20 doses. 1 cycle = 28 days. Maintenance: Zanubrutinib, 160mg PO BID
Induction: Zanubrutinib and R-BAC 6 cycles Consolidation: ASCT(If eligible for transplantation),Otherwise, the patient was directly entered into maintenance treatment Maintenance: Zanubrutinib continued until progression
Objective Response rate after induction
Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: 3 yeas
Complete remission rate after Interim treatment
Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: 3 years
MRD negativity rate after induction
MRD negativity rate after induction treatment
Time frame: 3 years
Progression free survival (PFS)
The time from start of treatment to progression or death from any cause
Time frame: 5 years
Overall survival (OS)
The time from start of treatment to death from any cause
Time frame: 5 years
Percentage of Participants With Adverse Events
Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.