Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558604
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
A Phase II Study Evaluating Glofitamab in Combination With Venetoclax Plus Zanubrutinib or Venetoclax Alone in Subjects With Untreated or RelapsedRefractory High-risk Mantle-cell Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Multicenter Open-label Study Evaluating Glofitamab in Combination With Venetoclax Plus Zanubrutinib or Venetoclax Alone in Subjects With Untreated or RelapsedRefractory High-risk Mantle-cell Lymphoma
Status:
NOT_YET_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:
GLOASIS
Brief Summary:
This open-label multicenter three cohorts phase II study is designed to assess a combination of ZanubrutinibVenetoclaxGlofitamab or VenetoclaxGlofitamab in high-risk subjects with either first line or RR Mantle Cell Lymphoma MCL
Three independent cohorts will be run
Cohort A will include subjects with a primary refractory or progressive disease within 24 months from initiation of first line treatment POD 24
Cohort B will be open for subjects with RR MCL and refractory or progressive to a BTK inhibitor given previously 24 months if first line
Cohort C will only enrol newly diagnosed and untreated MCL subjects with very high-risk features
Three independent cohorts will be run
Cohort A will include subjects with a primary refractory or progressive disease within 24 months from initiation of first line treatment POD 24
Cohort B will be open for subjects with RR MCL and refractory or progressive to a BTK inhibitor given previously 24 months if first line
Cohort C will only enrol newly diagnosed and untreated MCL subjects with very high-risk features
Detailed Description:
Cohort A 40 subjects will be included and treated Cohort B 36 subjects will be included and treated Cohort C 24 subjects will be included and treated
Subjects in cohorts A and C will receive during induction phase 12 cycles of ZanubrutinibVenetoclaxGlofitamab and during maintenance phase 23 cycles of ZanubrutinibVenetoclax
Subjects in cohort B will receive during induction phase 12 cycles of VenetoclaxGlofitamab and during maintenance phase 23 cycles of Venetoclax
Subjects in cohorts A and C will receive during induction phase 12 cycles of ZanubrutinibVenetoclaxGlofitamab and during maintenance phase 23 cycles of ZanubrutinibVenetoclax
Subjects in cohort B will receive during induction phase 12 cycles of VenetoclaxGlofitamab and during maintenance phase 23 cycles of Venetoclax
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