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

ConditionMantle Cell Lymphoma (MCL)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Participants known to be participating in investigational studies at the time of liso-cel infusion.

Participants treated with non-conforming CAR T-cell product.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Lisocabtagene maraleucel

    Biological/Vaccine

    According to US Prescribing Information

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Participants treated with lisocabtagene maraleucel1 intervention

Trial outcomes

Primary outcomes

1

Adverse events (AEs)

Time frame
Up to 15 years

Secondary outcomes

1

Complete remission rate (CRR)

Time frame
Up to 15 years
2

Overall response rate (ORR)

Time frame
Up to 15 years
3

Progression-free survival (PFS)

Time frame
Up to 15 years
4

Overall survival (OS)

Time frame
Up to 15 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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