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

Terminated

• Conditions: Multiple Myeloma; Chronic Lymphocytic Leukemia; Follicular Lymphoma; Non Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma; Mantle Cell Lymphoma
• Interventions: Genetic: JCAR017; Genetic: JCARH125

• Registration Number: NCT03436771
• Lead Sponsor: Juno Therapeutics, a Subsidiary of Celgene

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-12
• Study First Submitted QC: 2018-02-12
• Study Start: 2018-02-19
• Study First Posted: 2018-02-19
• Primary Completion: 2018-07-20
• Study Completion: 2018-07-20
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-30
• Last Update Posted: 2020-05-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
JCAR017-treated	JCAR017	Patients who received previous treatment with JCAR017
JCARH125-treated	JCARH125	Patients who received previous treatment with JCARH125

Primary Outcome Measures

Name	Time	Method
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
Proportion of patients with adverse events	15 years from last treatment

Secondary Outcome Measures

Name	Time	Method
Overall survival	15 years from last treatment
Progression-free survival	15 years from last treatment

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

City of Hope; 🇺🇸 Duarte, California, United States