Long-Term Follow-up Study for Patients Previously Treated With JCAR015
Long-Term Follow-up Protocol for Subjects Treated With JCAR015
1 other identifier
observational
15
1 country
4
Brief Summary
This study will provide long-term follow-up for patients who have received treatment with JCAR015 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of JCAR015 for evaluation of delayed adverse events, presence of persisting JCAR015 vector sequences, and survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2016
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2016
CompletedFirst Posted
Study publicly available on registry
June 24, 2016
CompletedStudy Start
First participant enrolled
August 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2021
CompletedJune 3, 2022
May 1, 2022
5.1 years
June 21, 2016
June 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Proportion of patients with adverse events
Every year for up to 15 years post-treatment
Proportion of patients with detectable JCAR015 vector sequences during first 5 years post-treatment
Every 6 months for the first 5 years post-treatment
Proportion of patients with detectable JCAR015 vector sequences between 5 and 15 years post-treatment
Every year from 5 years post-treatment to up to 15 years post-treatment
Survival
Up to 15 years
Study Arms (1)
JCAR015-treated
Patients who received previous treatment with JCAR015
Interventions
No study drug is administered in this study. Patients who received JCAR015 in a previous trial will be evaluated in this trial for long-term safety and efficacy.
Eligibility Criteria
Patients previously treated with JCAR015 in a prior clinical trial
You may qualify if:
- Patients who have received at least one dose of JCAR015 in a previous treatment protocol.
- Patients who have provided informed consent for the long-term follow-up study prior to study participation.
You may not qualify if:
- None. All patients who have previously received JCAR015 treatment are eligible for this long-term follow-up study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Northwestern University
Chicago, Illinois, 60611, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
Washington University School of Medicine
St Louis, Missouri, 63110-1093, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Biospecimen
Genomic DNA prepared from peripheral blood mononuclear cells
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2016
First Posted
June 24, 2016
Study Start
August 30, 2016
Primary Completion
October 22, 2021
Study Completion
October 22, 2021
Last Updated
June 3, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share