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Spots Global Cancer Trial Database for A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)

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Trial Identification

Brief Title: A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)

Official Title: A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting

Study ID: NCT03744676

Study Description

Brief Summary: This is an open-label, multicenter, Phase 2 study to determine the safety, PK, and efficacy of lisocabtagene maraleucel (JCAR017) in subjects who have relapsed from, or are refractory to, two lines of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) in the outpatient setting. Subjects will receive treatment with JCAR017 and will be followed for up to 2 years.

Detailed Description: This is an open-label, multicenter, Phase 2 study to assess the safety and antitumor activity in adult patients with relapsed or refractory B-cell non-Hodgkin Lymphoma when administered with lisocabtagene maraleucel (JCAR017) in the outpatient setting. Upon the successful product generation of lisocabtagene maraleucel, subjects will enter the treatment phase of the study. Treatment will include lymphodepleting chemotherapy followed by lisocabtagene maraleucel administration. Subjects will then enter the post-treatment follow-up phase of the study and will be followed for approximately 24 months for safety, disease status, health-related quality of life (HRQoL), and survival. Long-term follow-up will continue under a separate long-term follow-up protocol, per health regulatory authority guidelines, currently up to 15 years after the last lisocabtagene maraleucel administration.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Local Institution - 0057, Los Angeles, California, United States

Local Institution - 0060, Denver, Colorado, United States

Local Institution - 0089, Miami, Florida, United States

Local Institution - 0081, Orlando, Florida, United States

Local Institution - 0065, Indianapolis, Indiana, United States

Local Institution - 0069, Wichita, Kansas, United States

Local Institution - 0064, Louisville, Kentucky, United States

Local Institution - 0101, Southfield, Michigan, United States

Local Institution - 0052, East Brunswick, New Jersey, United States

Local Institution - 0066, Morristown, New Jersey, United States

Local Institution - 0041, Albany, New York, United States

Local Institution - 0039, Cincinnati, Ohio, United States

Local Institution - 0098, Eugene, Oregon, United States

Local Institution - 0051, Portland, Oregon, United States

Lancaster General Hospital, Lancaster, Pennsylvania, United States

Local Institution - 0037, Greenville, South Carolina, United States

Local Institution - 0063, Nashville, Tennessee, United States

Local Institution - 0097, Dallas, Texas, United States

Local Institution - 0061, San Antonio, Texas, United States

Baylor Scott and White Health, Temple, Texas, United States

Local Institution - 0096, Tyler, Texas, United States

Local Institution - 0074, Salt Lake City, Utah, United States

Local Institution - 0036, Norfolk, Virginia, United States

Contact Details

Name: Bristol-Myers Squibb

Affiliation: Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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