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Clinical Trials in France / NCT02735083
Active, not recruiting Phase 1

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

NCT02735083 · tracked via the Priya Life Science France tracker
Sponsor
Institut de Recherches Internationales Servier
Phase
Phase 1
Started
2021-03-10
Last updated
2025-04-11

Condition(s) studied

Advanced Lymphoid Leukemia

Investigational drug(s) / intervention(s)

UCART19 follow-up

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.

Study summary

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

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Written informed consent obtained prior any study-specific procedure (patient or parent(s) or legal representative) * Patient dosed with UCART19 who completed or discontinued early from a sponsored or from any investigator-initiated study that tested UCART19, or patients who were administered UCART19 under a special access scheme (compassionate use); * Female patients of childbearing potential and male patients with partners of childbearing potential must continue to use an effective method of birth control as well as their partners for a 12-month duration after the last UCART19 administration. Exclusion Criteria: \- No exclusion criteria for this study

Primary outcome measure(s)

  • Long-term safety of UCART19 with or without alemtuzumab — Up to 15 Year
    * Number, duration, outcome of all adverse events (AE) within 12 months post last UCART19 infusion * Number, duration, outcome of adverse events of special interest (AESI) up to the end of the study * Proportion of patients with adverse events leading to death up to the end of the study * For paediatric patients: assesment of the potential impact on growth curve and puberty

Trial sites (16)

FacilityCityRegionStatus
Children's Hospital Los Angeles Los Angeles California
Colorado Blood Cancer Institute Denver Colorado
Moffit Cancer Center Tampa Florida
Massachussetts General Hospital Charlestown Massachusetts
Children's Hospital of Philadelphia Philadelphia Pennsylvania
University of Texas Southwestern Medical Center Dallas Texas
University of Texas MD Anderson Cancer Center Houston Texas
Hôpital Saint-Louis Paris France
Hôpital Robert-Debré Paris France
Hôpital Saint-Antoine Paris France
Kyushyu University Hospital Fukuoka Japan
Hokkaido University Hospital Sapporo Japan
Hospital San Juan De Dios Barcelona Spain
King's College Hospital NHS Foundation Trust London United Kingdom
UCL Great Ormond Hospital London United Kingdom
The Christie NHS Foundation Trust Manchester United Kingdom

More Institut de Recherches Internationales Servier trials in France

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Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation Recruiting
Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation Recruiting
Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation Active, not recruiting
A First-in-human Study of S230815 in Pediatric Participants With KCNT1-related Developmental and Epileptic Encephalopathy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02735083 on ClinicalTrials.gov ↗ ← All trials in France