Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427213
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-19
Brief Title:
This is a Phase II Open-label Multicentre Study of Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma
Sponsor:
Henan Cancer Hospital
Organization:
Henan Cancer Hospital
Study Overview
Official Title:
A Study of the Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase II open-label multicentre study of Zanubrutinib-containing regimens in patients with newly diagnosed mantle cell lymphoma
Detailed Description:
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 armpatients 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 armpatiens 65 yearsand meet one or more of the following risk factors TP53 mutation blastoidpleomorphic type high sMIPI score patients start with 6 cycles of induction therapy with zanubrutinib combined with R-BAC regimen and the patients who achieve CRPR and meet the transplantation criteria will receive ASCT consolidationand then received maintenance therapy with zanubrutinib otherwise Patients who is ineligible for transplantationwill take zanubrutinib orally until intolerable toxicity or disease progression
In elderly patients armpatients 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 armpatiens 65 yearsand meet one or more of the following risk factors TP53 mutation blastoidpleomorphic type high sMIPI score patients start with 6 cycles of induction therapy with zanubrutinib combined with R-BAC regimen and the patients who achieve CRPR and meet the transplantation criteria will receive ASCT consolidationand then received maintenance therapy with zanubrutinib otherwise Patients who is ineligible for transplantationwill take zanubrutinib orally until intolerable toxicity or disease progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None