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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elder Patients(≥65) | Experimental | Induction: Zanubrutinib and Obinutuzumab 1year Maintenance: Zanubrutinib continued until progression |
|
| Young Patients with High risk (≥18,<65) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib,Obinutuzumab | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response rate after induction | Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria. | 3 yeas |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate after Interim treatment | Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria. | 3 years |
| MRD negativity rate after induction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| keshu Zhou | Contact | 0371-65587306 | drzhouks77@163.com |
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|
| Zanubrutinib and R-BAC | Drug | 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 |
|
MRD negativity rate after induction treatment
| 3 years |
| Progression free survival (PFS) | The time from start of treatment to progression or death from any cause | 5 years |
| Overall survival (OS) | The time from start of treatment to death from any cause | 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 | 5 years |
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
| C543332 | obinutuzumab |
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