Long-Term Follow-up Study for Patients Previously Treated With JCAR015

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Long-Term Follow-up Protocol for Subjects Treated With JCAR015

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813252
• Other study ID #: 015002
• Status: Completed
• Start date: August 30, 2016
• Est. completion date: October 22, 2021

Study information

• Verified date: May 2022
• 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 JCAR015 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of JCAR015 for evaluation of delayed adverse events, presence of persisting JCAR015 vector sequences, and survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 22, 2021
• Est. primary completion date: October 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients who have received at least one dose of JCAR015 in a previous treatment protocol.

• Patients who have provided informed consent for the long-term follow-up study prior to study participation.

Exclusion criteria:

• None. All patients who have previously received JCAR015 treatment are eligible for this long-term follow-up study.

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Genetic:
• JCAR015
No study drug is administered in this study. Patients who received JCAR015 in a previous trial will be evaluated in this trial for long-term safety and efficacy.

Locations

Country	Name	City	State
United States	Johns Hopkins Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	Northwestern University	Chicago	Illinois
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Washington University School of Medicine	Saint Louis	Missouri

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		Every year for up to 15 years post-treatment
Primary	Proportion of patients with detectable JCAR015 vector sequences during first 5 years post-treatment		Every 6 months for the first 5 years post-treatment
Primary	Proportion of patients with detectable JCAR015 vector sequences between 5 and 15 years post-treatment		Every year from 5 years post-treatment to up to 15 years post-treatment
Primary	Survival		Up to 15 years