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Active, Not Recruiting

NCT Number: NCT02735083

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Lymphoid Leukemia

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hôpital Robert-Debré, Paris, France

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

UCART19 follow-up

Biological

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.

Primary outcomes

  1. Long-term safety of UCART19 with or without alemtuzumab

    Time frame: 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

Secondary outcomes

  1. Assessment of long-term anti tumor activity of UCART19

    Time frame: Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing then every 6 months up to Year 3, then yearly up to Year 15

  2. Proportion of patients who underwent allogeneic HSCT (Hematopoietic Stem Cell Transplantation) for patients treated with UCART19

    Time frame: Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15

  3. Time to transplant for patients treated with UCART19

    Time frame: Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15

  4. Assessment of overall survival

    Time frame: Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15

  5. Proportion of patients with detectable UCART19 levels in blood

    Time frame: Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing (If no more UCART19 detectable at the Month 12 visit), then every 6 months up to Year 3, then yearly up to Year 15 or the first evidence of no more detectable UCART19 (if earlier)

  6. Proportion of patients with detectable UCART19 levels in bone marrow

    Time frame: Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15

Sponsors and collaborators

Lead sponsor

Institut de Recherches Internationales Servier

Other

Collaborators

  • ADIR, a Servier Group company

Registry information

Official study title

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)

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Apr 12, 2016
Registry last updated
Apr 11, 2025

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.