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A Study of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treated With Lisocabtagene Maraleucel in the Post-Marketing Setting

ConditionsChronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)
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 characterize the long-term safety of lisocabtagene maraleucel (liso-cel), focusing on patients treated in the chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) indication, and will be part of post-marketing liso-cel pharmacovigilance activities

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Participants known to be participating in investigational studies at the time of lisocabtagene maraleucel infusion

Patients treated with non-conforming CAR T-cell product

Trial population

The study population will include adults with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that are being treated with lisocabtagene maraleucel and are registered within the Center for International Blood and Marrow Transplant Research (CIBMTR) registry.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Lisocabtagene maraleucel

    Biological/Vaccine

    According to the United States 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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