Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647732
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Zanubrutinib Plus Rituximab As Front-line Treatment for Mucosa-associated Lymphoid Tissue Lymphoma MALT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Zanubrutinib Plus Rituximab As Front-line Treatment for Mucosa-associated Lymphoid Tissue Lymphoma MALT a Single-arm Open-label Multicenter Phase II StudyZAMA
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective single-arm multicenter phase II clinical trial to evaluate the efficacy and safety of Zanubrutinib in combination with Rituximab as a first-line treatment for patients with mucosa-associated lymphoid tissue MALT extranodal marginal zone lymphoma
Detailed Description:
The purpose of this study is to evaluate the efficacy and safety of Zanubrutinib in combination with Rituximab as a first-line treatment for patients with mucosa-associated lymphoid tissue MALT extranodal marginal zone lymphoma
Treatrment
1 Rituximab 375 mgm² administered once a week in Cycle 1 C1 and on Day 1 D1 of Cycles 2-6 C2-C6
2 Zanubrutinib 160 mg administered twice daily from Day 1 to Day 28 D1-D28 Each cycle lasts 28 days After 6 cycles of treatment patients who achieve complete remission CR will end treatment and enter observation follow-up Patients with partial remission PR or stable disease SD will receive 2 additional cycles
The primary study endpoint is the complete remission rate of Zanubrutinib in combination with Rituximab in the treatment of newly diagnosed mucosa-associated lymphoid tissue MALT extranodal marginal zone lymphoma
Treatrment
1 Rituximab 375 mgm² administered once a week in Cycle 1 C1 and on Day 1 D1 of Cycles 2-6 C2-C6
2 Zanubrutinib 160 mg administered twice daily from Day 1 to Day 28 D1-D28 Each cycle lasts 28 days After 6 cycles of treatment patients who achieve complete remission CR will end treatment and enter observation follow-up Patients with partial remission PR or stable disease SD will receive 2 additional cycles
The primary study endpoint is the complete remission rate of Zanubrutinib in combination with Rituximab in the treatment of newly diagnosed mucosa-associated lymphoid tissue MALT extranodal marginal zone lymphoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None