Signatures of Response and Resistance to Mosunetuzomab in... | NCT05529524

Studies
Signatures of Response and Resistance to Mosunetuzomab in Follicular Lymphomas (FL)

NCT05529524

Sponsor

The Lymphoma Academic Research Organisation

Status

Completed

Last Update Posted

Jan 24, 2025Actual

Enrollment

6Actual

Phase

Not provided

Conditions

Follicular Lymphoma

Interventions

Not provided

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

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 7, 2022Actual

Primary Completion Date

Jan 22, 2024Actual

Completion Date

Jan 22, 2024Actual

First Submitted Date

Sep 2, 2022

First Submission Date that Met QC Criteria

Sep 2, 2022

First Posted Date

Sep 7, 2022Actual

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

Jan 23, 2025

Last Update Posted Date

Jan 24, 2025Actual

Name	Class
Roche Pharma AG	INDUSTRY

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

Mosunetuzumab is a T-cell bispecific antibody targeting CD20 and CD3 aiming to redirect T cells to engage and eliminate malignant B cells. Bispecific antibodies (BsAb) are a promising treatment option which can induce long-term responses in refractory and relapsed B cell lymphoma patients. However, the factors determining the quality and duration of responses are poorly understood.

Detailed Description

the objective is to produce a collection of great scientific interest for lymphoma research from CELESTIMO's clinical trial patients' samples to increase knowledge of treatment with mosunetuzumab's for patients with follicular lymphoma (FL).

study population involves patients participating to CELESTIMO study in France. 10 sites are expected in this biobanking protocol study

Biological samples will collected as part of routine care (tissue and blood already sampled in routine and/or CELESTIMO study) at screening, at C4, at C12 or at progressive disease/relapse.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

6Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Capacity of sampling	number of samples collected	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

patients who participate to CELESTIMO study (NCT04712097)

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

patients who participate to CELESTIMO study (NCT04712097)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Camille Laurent, MD	Oncopole - Toulouse France	Principal Investigator
Karin Tarte, PhD	Micro-environnement et cancer (MICA) - Rennes France	Principal Investigator
Franck MORSCHHAUSER, MD	Centre Hospitalier Universitaire de Lille - Lille France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier de La Cote Basque; Hematologie		Bayonne		64109	France
Hopital Claude Huriez; Hematologie

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

Condition Browse Module

MeSH Terms

ID	Term
D008224	Lymphoma, Follicular
D009369	Neoplasms
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders

Ancestor Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D008232	Lymphoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided