Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-31 @ 10:54 PM
Study NCT ID:
NCT06670105
Status:
WITHDRAWN
Last Update Posted:
2025-09-17
First Post:
2024-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Trial of Glofitamab for Minimal Residual Disease in Patients With Large B-cell Lymphoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Phase 2 Trial of Glofitamab for Minimal Residual Disease in Patients With Large B-cell Lymphoma
Status:
WITHDRAWN
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI Request
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to learn if glofitamab can help to prevent recurrence of LBCL in patients who have achieved CR after standard first-line therapy but have tested positive for MRD. The safety of glofitamab will also be studied.
Detailed Description:
Primary Objective:
To determine the rate of undetectable MRD following treatment with glofitamab in patients with LBCL who were MRD positive at the end of standard first line treatment
Secondary Objective:
To determine progression-free survival (PFS), overall survival (OS), and evaluate safety of glofitamab as treatment for patients with LBCL who are MRD positive at end of standard first line treatment
Exploratory Objective:
To determine the biomarkers of response and mechanisms of resistance to glofitamab in LBCL
To determine the kinetics of T-cell activation and exhaustion in patients treated with gofitamab to eliminate MRD
To determine the rate of undetectable MRD following treatment with glofitamab in patients with LBCL who were MRD positive at the end of standard first line treatment
Secondary Objective:
To determine progression-free survival (PFS), overall survival (OS), and evaluate safety of glofitamab as treatment for patients with LBCL who are MRD positive at end of standard first line treatment
Exploratory Objective:
To determine the biomarkers of response and mechanisms of resistance to glofitamab in LBCL
To determine the kinetics of T-cell activation and exhaustion in patients treated with gofitamab to eliminate MRD
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: