Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563505
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With RelapsedRefractory Marginal Zone Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With RelapsedRefractory Marginal Zone Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
To assess the efficacy and safety of mosunetuzumab combined with zanubrutinib in patients with relapsed or refractory MZL
Detailed Description:
Primary Objectives
To determine the safety and efficacy of mosunetuzumab in combination with zanubrutinib as determined by best complete response CR rate of combination treatment for patients with relapsed or refractory marginal zone lymphoma MZL
Secondary Objectives
To determine best overall response rate ORR duration of response DOR time to next treatment progression-free survival PFS overall survival OS and evaluation of tolerability of mosunetuzumab and zanubrutinib as treatment for patients with relapsedrefractory MZL
Exploratory Objective
To determine the impact of total metabolic tumor volume to ORR CR rate and survival outcomes
To determine the biomarkers that correlates with response and mechanisms of resistance to mosunetuzumab and zanubrutinib in relapsedrefractory MZL
To determine the surrogate endpoint for future trials in MZL
To determine the safety and efficacy of mosunetuzumab in combination with zanubrutinib as determined by best complete response CR rate of combination treatment for patients with relapsed or refractory marginal zone lymphoma MZL
Secondary Objectives
To determine best overall response rate ORR duration of response DOR time to next treatment progression-free survival PFS overall survival OS and evaluation of tolerability of mosunetuzumab and zanubrutinib as treatment for patients with relapsedrefractory MZL
Exploratory Objective
To determine the impact of total metabolic tumor volume to ORR CR rate and survival outcomes
To determine the biomarkers that correlates with response and mechanisms of resistance to mosunetuzumab and zanubrutinib in relapsedrefractory MZL
To determine the surrogate endpoint for future trials in MZL
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