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NCT02735083 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Advanced Lymphoid Leukemia, sponsored by Institut de Recherches Internationales Servier.

Active
Registry status
Phase 1
Development phase
28
Enrollment target
16
Study locations

NCT02735083: Active Phase 1 study of Advanced Lymphoid Leukemia, sponsored by Institut de Recherches Internationales Servier.

NCT02735083 is a Phase 1 study of Advanced Lymphoid Leukemia that is active but no longer recruiting, run by Institut de Recherches Internationales Servier. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). The trial reports 16 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02735083, a Phase 1 study of Advanced Lymphoid Leukemia, is active but no longer recruiting, sponsored by Institut de Recherches Internationales Servier.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
28 participants
Enrollment target
16
Study locations

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.

Primary Outcome

* 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

Conditions Studied

Interventions

  • BIOLOGICAL UCART19 follow-up

Study Locations (16)

Other

  • Hôpital Saint-Louis - Paris
  • Hôpital Robert-Debré - Paris
  • Hôpital Saint-Antoine - Paris
  • Kyushyu University Hospital - Fukuoka
  • Hokkaido University Hospital - Sapporo
  • Hospital San Juan De Dios - Barcelona
  • King's College Hospital NHS Foundation Trust - London
  • UCL Great Ormond Hospital - London
  • The Christie NHS Foundation Trust - Manchester

Texas

  • University of Texas Southwestern Medical Center - Dallas
  • University of Texas MD Anderson Cancer Center - Houston

California

  • Children's Hospital Los Angeles - Los Angeles

Colorado

  • Colorado Blood Cancer Institute - Denver

Florida

  • Moffit Cancer Center - Tampa

Massachusetts

  • Massachussetts General Hospital - Charlestown

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2021-03-10
Est. Completion 2028-09
Phase Phase 1

What the registry record for NCT02735083 still lists

NCT02735083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).

The record links to 1 condition, with Advanced Lymphoid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which UCART19 follow-up is the first listed.

NCT02735083 lists 16 locations in 7 states (Other, Texas, California).

Frequently Asked Questions

What is clinical trial NCT02735083 about?

NCT02735083 is a clinical study titled "A Study to Evaluate the Long-term Safety of Patients With Advanced Lymphoid Leukemia Who Have Been Previously Administered With UCART19". The purpose of this study is to evaluate the long-term safety and efficacy of UCART19 administration to patients with advanced lymphoid leukemia.

What is the current status of trial NCT02735083?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2021-03-10. Estimated completion is 2028-09.

What conditions does trial NCT02735083 study?

This clinical trial studies the following conditions: Advanced Lymphoid Leukemia.

What interventions are being tested in trial NCT02735083?

The interventions under investigation include: UCART19 follow-up (BIOLOGICAL).

Who is sponsoring clinical trial NCT02735083?

This trial is sponsored by Institut de Recherches Internationales Servier, which has 27 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02735083 being conducted?

This trial has 16 study locations across California, Colorado, Florida, Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT02735083's enrollment target sits among peer trials

28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02735083, the US trial registry maintained by the National Library of Medicine. NCT02735083 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.