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

NCT ID: NCT03436771

Last Updated: 2020-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-19

Study Completion Date

2018-07-20

Brief Summary

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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.

Detailed Description

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Conditions

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Non Hodgkin Lymphoma Multiple Myeloma Chronic Lymphocytic Leukemia Diffuse Large B Cell Lymphoma Mantle Cell Lymphoma Follicular Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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JCAR017-treated

Patients who received previous treatment with JCAR017

JCAR017

Intervention Type GENETIC

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

JCARH125

Intervention Type GENETIC

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.

Interventions

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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.

Intervention Type 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.

Intervention Type GENETIC

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juno Therapeutics, a Subsidiary of Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob Garcia, MD

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

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City of Hope

Duarte, California, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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LTFU001

Identifier Type: -

Identifier Source: org_study_id

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