A Study of Patients With Relapsed/Refractory Mantle Cell Lymphoma Treated With Lisocabtagene Maraleucel in the Post-Marketing Setting

NCT ID: NCT06788652

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-04

Study Completion Date

2044-09-30

Brief Summary

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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

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Conditions

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Mantle Cell Lymphoma (MCL)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Participants treated with lisocabtagene maraleucel

Lisocabtagene maraleucel

Intervention Type BIOLOGICAL

According to US Prescribing Information

Interventions

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Lisocabtagene maraleucel

According to US Prescribing Information

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Center for International Blood and Marrow Transplant Research (CIBMTR)

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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BMS Study Connect Contact Center www.BMSStudyConnect.com

Role: CONTACT

855-907-3286

First line of the email MUST contain NCT # and Site #.

Role: CONTACT

Related Links

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Other Identifiers

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CA082-1093

Identifier Type: -

Identifier Source: org_study_id

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