Long-Term Follow-up Study for Patients Previously Treated With JCAR015
Sponsor
Juno Therapeutics, a Subsidiary of Celgene (Industry)
Overall Status
Completed
CT.gov ID
NCT02813252
Collaborator
(none)
15
4
61.7
3.8
0.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
15 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Long-Term Follow-up Protocol for Subjects Treated With JCAR015
Actual Study Start Date
:
Aug 30, 2016
Actual Primary Completion Date
:
Oct 22, 2021
Actual Study Completion Date
:
Oct 22, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| JCAR015-treated Patients who received previous treatment with JCAR015 |
Genetic: JCAR015
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.
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
-
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.
Exclusion criteria:
- None. All patients who have previously received JCAR015 treatment are eligible for this long-term follow-up study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 2 | Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | United States | 21231 |
| 3 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110-1093 |
| 4 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Juno Therapeutics, a Subsidiary of Celgene
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Juno Therapeutics, a Subsidiary of Celgene
ClinicalTrials.gov Identifier:
NCT02813252
Other Study ID Numbers:
- 015002
First Posted:
Jun 24, 2016
Last Update Posted:
Jun 3, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Juno Therapeutics, a Subsidiary of Celgene
Additional relevant MeSH terms: