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

NCT06788639 | Recruiting FDA Drug

• 1 other identifier: CA082-1092
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL)

Keywords

Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL)

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs)

  Up to 15 years

Secondary Outcomes (4)

• Complete remission rate (CRR

  Up to 15 years

• Overall response rate (ORR)

  Up to 15 years

• Progression-free survival (PFS)

  Up to 15 years

• Overall survival (OS)

  Up to 15 years

Study Arms (1)

Participants treated with lisocabtagene maraleucel

Biological: Lisocabtagene maraleucel

Interventions

Lisocabtagene maraleucel BIOLOGICAL

According to the United States Prescribing Information

Participants treated with lisocabtagene maraleucel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Juno Therapeutics, Inc., a Bristol-Myers Squibb Company: lead

Study Sites (1)

Center for International Blood and Marrow Transplant Research (CIBMTR)

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: February 4, 2025
• Primary Completion (Estimated): June 30, 2044
• Study Completion (Estimated): June 30, 2044
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)