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Long-term Follow-up Study for Patients Previously Treated With a Juno CAR T-Cell Product

Sponsor
Juno Therapeutics, a Subsidiary of Celgene (Industry)
Overall Status
Terminated
CT.gov ID
NCT03436771
Collaborator
(none)
4
Enrollment
2
Locations
5
Actual Duration (Months)
2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: JCAR017
  • Genetic: JCARH125

Study Design

Study Type:
Observational
Actual Enrollment :
4 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Long-Term Follow-up Protocol for Subjects Treated With a CAR T-Cell Product on a Juno-Sponsored Clinical Trial
Actual Study Start Date :
Feb 19, 2018
Actual Primary Completion Date :
Jul 20, 2018
Actual Study Completion Date :
Jul 20, 2018

Arms and Interventions

Arm Intervention/Treatment
JCAR017-treated

Patients who received previous treatment with JCAR017

Genetic: JCAR017
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.
JCARH125-treated

Patients who received previous treatment with JCARH125

Genetic: JCARH125
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.

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients with adverse events [15 years from last treatment]

  2. Proportion of patients with detectable viral vector sequences [15 years from last treatment]

  3. Proportion of patients with detectable RCR or RCL [15 years from last treatment]

Secondary Outcome Measures

  1. Overall survival [15 years from last treatment]

  2. Progression-free survival [15 years from last treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:
  • None. All patients who have previously received treatment with a Juno CAR T-cell product are eligible for this long-term follow-up study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 City of Hope Duarte California United States 91010
2 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Juno Therapeutics, a Subsidiary of Celgene

Investigators

  • Study Director: Jacob Garcia, MD, Sponsor GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Juno Therapeutics, a Subsidiary of Celgene
ClinicalTrials.gov Identifier:
NCT03436771
Other Study ID Numbers:
  • LTFU001
First Posted:
Feb 19, 2018
Last Update Posted:
May 4, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Juno Therapeutics, a Subsidiary of Celgene
long-term follow-up
chimeric antigen receptor (CAR) T cells
JCAR017
JCARH125
Additional relevant MeSH terms:
Lymphoma
Multiple Myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse

Study Results

No Results Posted as of May 4, 2020