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

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University, Chicago, Illinois, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JCAR015

Genetic

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.

Primary outcomes

Proportion of patients with adverse events

Time frame: Every year for up to 15 years post-treatment
Proportion of patients with detectable JCAR015 vector sequences during first 5 years post-treatment

Time frame: Every 6 months for the first 5 years post-treatment
Proportion of patients with detectable JCAR015 vector sequences between 5 and 15 years post-treatment

Time frame: Every year from 5 years post-treatment to up to 15 years post-treatment
Survival

Time frame: Up to 15 years

Sponsors and collaborators

Lead sponsor

Juno Therapeutics, a Subsidiary of Celgene

Industry

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2021
Study completion: 2021
First posted: Jun 24, 2016
Registry last updated: Jun 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed