NCT02735083

A Study to Evaluate the Long-term Safety of Patients With Advanced Lymphoid Leukemia Who Have Been Previously Administered With UCART19

Long-term Follow-up Study of Patients Who Have Previously Been Exposed to UCART19 (Allogeneic Engineered T-cells Expressing a Lentiviral-based Anti-CD19 Chimeric Antigen Receptor)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety and efficacy of UCART19 administration to patients with advanced lymphoid leukemia.

Conditions

• Advanced Lymphoid Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	UCART19 follow-up	UCART19 will not be administered during the study period. Patients who will be rolled-over from the parent study to this long term follow-up study, have previously received UCART19. The roll-over occurs at the end of the parent study, or at any time after UCART19 administration, in case of premature discontinuation from the parent study.

Timeline

• Start date: 2021-03-10
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2016-04-12
• Last updated: 2025-04-11

Locations

16 sites across 5 countries: United States, France, Japan, Spain, United Kingdom

Regulatory

• FDA-regulated drug study