Study Stopped
Eligible subjects will be enrolled in Celgene's long-term follow-up protocol for subjects previously treated with a CAR T-cell product.
Long-term Follow-up Study for Patients Previously Treated With a Juno CAR T-Cell Product
Long-Term Follow-up Protocol for Subjects Treated With a CAR T-Cell Product on a Juno-Sponsored Clinical Trial
1 other identifier
observational
4
1 country
2
Brief Summary
This study will provide long-term follow-up for patients who have received treatment with a Juno CAR T-cell product in a Juno-sponsored clinical trial. In this study, patients will be followed for up to 15 years after their last dose of Juno CAR T cells for evaluation of delayed adverse events, presence of persisting CAR T-cell vector sequences, presence of replication-competent retrovirus (RCR) or lentivirus (RCL), 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 Feb 2018
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2018
CompletedFirst Posted
Study publicly available on registry
February 19, 2018
CompletedStudy Start
First participant enrolled
February 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2018
CompletedMay 4, 2020
April 1, 2020
5 months
February 12, 2018
April 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Proportion of patients with adverse events
15 years from last treatment
Proportion of patients with detectable viral vector sequences
15 years from last treatment
Proportion of patients with detectable RCR or RCL
15 years from last treatment
Secondary Outcomes (2)
Overall survival
15 years from last treatment
Progression-free survival
15 years from last treatment
Study Arms (2)
JCAR017-treated
Patients who received previous treatment with JCAR017
JCARH125-treated
Patients who received previous treatment with JCARH125
Interventions
No drug is administered in this study. Patients who received JCAR017 in a previous trial will be evaluated in this trial for long-term safety and survival.
No drug is administered in this study. Patients who received JCARH125 in a previous trial will be evaluated in this trial for long-term safety and survival.
Eligibility Criteria
Patients previously treated with a Juno CAR T-cell product on a Juno-sponsored clinical trial
You may qualify if:
- Patients who have received at least one dose of a Juno CAR T-cell product (listed above) in a Juno-sponsored clinical trial
- Patients who have provided informed consent for the long-term follow-up study
You may not qualify if:
- None. All patients who have previously received treatment with a Juno CAR T-cell product are eligible for this long-term follow-up study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
City of Hope
Duarte, California, 91010, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Biospecimen
Genomic DNA prepared from peripheral blood mononuclear cells
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jacob Garcia, MD
Sponsor GmbH
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2018
First Posted
February 19, 2018
Study Start
February 19, 2018
Primary Completion
July 20, 2018
Study Completion
July 20, 2018
Last Updated
May 4, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share