Acute Lymphoblastic Leukemia
Conditions
Keywords
long-term follow-up, chimeric antigen receptor (CAR) T cells, JCAR015
Brief 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.
Interventions
GENETICJCAR015
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.
Sponsors
Juno Therapeutics, a Subsidiary of Celgene
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with adverse events | Every year for up to 15 years post-treatment |
| Proportion of patients with detectable JCAR015 vector sequences during first 5 years post-treatment | 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 | Every year from 5 years post-treatment to up to 15 years post-treatment |
| Survival | Up to 15 years |
Countries
United States
Outcome results
None listed