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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03436771
Other study ID # LTFU001
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date February 19, 2018
Est. completion date July 20, 2018

Study information

Verified date April 2020
Source Juno Therapeutics, a Subsidiary of Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date July 20, 2018
Est. primary completion date July 20, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

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
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.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts
United States City of Hope Duarte California

Sponsors (1)

Lead Sponsor Collaborator
Juno Therapeutics, a Subsidiary of Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with adverse events 15 years from last treatment
Primary Proportion of patients with detectable viral vector sequences 15 years from last treatment
Primary Proportion of patients with detectable RCR or RCL 15 years from last treatment
Secondary Overall survival 15 years from last treatment
Secondary Progression-free survival 15 years from last treatment
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