Glofitamab in Real Life | NCT06994169

Studies
Glofitamab in Real Life

NCT06994169

Sponsor

The Lymphoma Academic Research Organisation

Status

Recruiting

Last Update Posted

Jun 3, 2026Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Large B-cell Lymphoma

Interventions

Glofitamab

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2025Actual

Primary Completion Date

Mar 27, 2026Actual

Completion Date

Dec 30, 2026Estimated

First Submitted Date

May 20, 2025

First Submission Date that Met QC Criteria

May 20, 2025

First Posted Date

May 29, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2026

Last Update Posted Date

Jun 3, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To date, more than 300 patients have been treated with Glofitamab in the Expanded Access Programme (EAP) in France. In this study, it is proposed to perform a retrospective analysis of some of these patients. The aim is to describe the efficacy and safety of Glofitamab in the largest reported real-world cohort, with an expected median follow-up of more than 9 months. Particular focus will be given to the relapsed or refractory chimeric antigen receptors-T (CAR-T) population to confirm the response rates (CRR: 35-39%) of Glofitamab in this population and to assess the optimal timing of therapy initiation [8, 15].

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients treated in EPA		Patients treated in Expanded Access Program to Glofitamab	Drug: Glofitamab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glofitamab	Drug	Glofitamab received for DLBCL in Early Phase Access	Patients treated in EPA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best Complete Response Rate (best CRR) during treatment, assessed by investigator according to Lugano 2014 criteria.		6 months

Secondary Outcomes

Measure	Description	Time Frame
Complete metabolic response rate and overall response rate (ORR) by investigator assessment according to Lugano 2014 criteria		1 month, 2 months, 3 months, 6 months
Progression-free survival (PFS)		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient enrolled in the French Glofitamab EAP for R/R DLBCL before 2024 November 1st, 2024
patient who received at least Obinutuzumab pretreatment and one infusion of Glofitamab
adult patient
patient who is informed of the study and who did not oppose to their data collection

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

French patients enrolled in the EAP before 1st of November 2024 and treated with at least Obinutuzumab pretreatment and one infusion of Glofitamab for R/R DLBCL We expect to collect data from 200-250 patients from this population with a minimum of 6 months of follow-up.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
PROJECT MANAGER	Contact	+33 4 72 66 93 33		glorel@lysarc.org

Overall Officials

Name	Affiliation	Role
Guillaume MANSON, MD	Lymphoma Study Association	Study Chair
Gilles CROCHET, MD	The Lymphoma Academic Research Organisation	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CH Victor Dupouy	Recruiting	Argenteuil		95100	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000720108	glofitamab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided