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Recruiting

NCT Number: NCT06788639

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

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

Recruiting

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Key information

Conditions

Chronic Lymphocytic Leukemia (CLL) Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Small Lymphocytic Lymphoma (SLL)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for International Blood and Marrow Transplant Research (CIBMTR)

Milwaukee, Wisconsin, 53226, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have been treated in the post-marketing setting with ≥1 infusion of lisocabtagene maraleucel used for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) within the approved indication and dosage per the United States Prescribing Information (USPI) and product specifications approved for commercial release in the USA

Exclusion criteria

  • Participants known to be participating in investigational studies at the time of lisocabtagene maraleucel infusion
  • Patients treated with non-conforming CAR T-cell product

Treatment and study plan

Lisocabtagene Maraleucel

Biological

According to the United States Prescribing Information

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

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Non-interventional Cohort Study of Patients Treated With Liso-cel (Lisocabtagene Maraleucel) for Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in the Post-Marketing Setting

Important dates

Study start
2025
Primary completion
2044
Study completion
2044
First posted
Jan 23, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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