A Study of Patients With Relapsed/Refractory Mantle Cell... | NCT06788652

Status Module

Record Verification Date

Feb 2025

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

Feb 4, 2025Actual

Primary Completion Date

Sep 30, 2044Estimated

Completion Date

Sep 30, 2044Estimated

First Submitted Date

Jan 17, 2025

First Submission Date that Met QC Criteria

Jan 17, 2025

First Posted Date

Jan 23, 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

Feb 21, 2025

Last Update Posted Date

Feb 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

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

The purpose of this study is to understand the long-term safety and effectiveness of lisocabtagene maraleucel (liso-cel) for the treatment of Mantle Cell Lymphoma (MCL).

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants treated with lisocabtagene maraleucel			Biological: Lisocabtagene maraleucel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lisocabtagene maraleucel	Biological	According to US Prescribing Information	Participants treated with lisocabtagene maraleucel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events (AEs)		Up to 15 years

Secondary Outcomes

Measure	Description	Time Frame
Complete remission rate (CRR)		Up to 15 years
Overall response rate (ORR)		Up to 15 years
Progression-free survival (PFS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Participants must have been treated in the postmarketing setting with at least 1 infusion of lisocabtagene maraleucel (Liso-cel) used for the treatment of Mantle Cell Lymphoma (MCL) according to the FDA-approved indication and dose range (ie, per the US Prescribing Information) and with a product meeting the specifications for commercial release approved in the USA

Exclusion Criteria:

Participants known to be participating in investigational studies at the time of liso-cel infusion.
Participants treated with non-conforming CAR T-cell product.

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

The study population will include adults diagnosed with Relapsed/Refractory Mantle Cell Lymphoma (MCL) who are registered within the Center for International Blood and Marrow Transplant Research (CIBMTR) registry and have been treated with lisocabtagene maraleucel.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
BMS Study Connect Contact Center www.BMSStudyConnect.com	Contact	855-907-3286		Clinical.Trials@bms.com
First line of the email MUST contain NCT # and Site #.	Contact

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for International Blood and Marrow Transplant Research (CIBMTR)	Recruiting	Milwaukee	Wisconsin	53226	United States

Label	URL
BMS Clinical Trial Information	View source
FDA Safety Alerts and Recalls	View source

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

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D020522	Lymphoma, Mantle-Cell

Ancestor Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases