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

Multiple Myeloma Clinical Trial

Official title:

Long-Term Follow-up Protocol for Subjects Treated With a CAR T-Cell Product on a Juno-Sponsored Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03436771
• Other study ID #: LTFU001
• Status: Terminated
• 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
• 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.

Related Conditions & MeSH terms

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

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