Ignite Creation Date:
2024-07-17 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500273
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-26
Brief Title:
Consolidation of First-Line MRD Remission with Cema-cel in Patients with LBCL
Sponsor:
Allogene Therapeutics
Organization:
Allogene Therapeutics
Study Overview
Official Title:
A Randomized Open-label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants with Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-09
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:
ALPHA3
Brief Summary:
This is a randomized open-label study in adult patients who have completed standard first line of therapy for large B-cell lymphoma LBCL and achieved a complete response or partial response suitable for observation but who have minimal residual disease MRD as detected by the Foresight CLARITY Investigational Use Only IUO MRD test powered by PhasED-Seq The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel cema-cel an allogeneic CD19 CAR T product as compared to standard of care observation
The study is conducted in 2 consecutive parts that will be enrolled continuously In Part A of the study participants with MRD are randomized to one of two treatment arms or an observation arm Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide administered with or without the anti-CD52 monoclonal antibody ALLO-647 Part A will culminate with the selection of the lymphodepletion regimen to advance to Part B Part B will evaluate the selected lymphodepletion regimen followed by cema-cel as compared with observation
The study is conducted in 2 consecutive parts that will be enrolled continuously In Part A of the study participants with MRD are randomized to one of two treatment arms or an observation arm Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide administered with or without the anti-CD52 monoclonal antibody ALLO-647 Part A will culminate with the selection of the lymphodepletion regimen to advance to Part B Part B will evaluate the selected lymphodepletion regimen followed by cema-cel as compared with observation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None