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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03436771
Enrollment
4
Registered
2018-02-19
Start date
2018-02-19
Completion date
2018-07-20
Last updated
2020-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

long-term follow-up, chimeric antigen receptor (CAR) T cells, JCAR017, JCARH125

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.

Interventions

GENETICJCAR017

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.

GENETICJCARH125

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.

Sponsors

Juno Therapeutics, a Subsidiary of Celgene
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with adverse events15 years from last treatment
Proportion of patients with detectable viral vector sequences15 years from last treatment
Proportion of patients with detectable RCR or RCL15 years from last treatment

Secondary

MeasureTime frame
Overall survival15 years from last treatment
Progression-free survival15 years from last treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026