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

Phase 1Active Not RecruitingNCT02735083

Institut de Recherches Internationales Servier28 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Advanced Lymphoid Leukemia

Interventions

UCART19 follow-upBIOLOGICAL

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (16)

Children's Hospital Los Angeles

Los Angeles, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Outcomes

Primary Outcomes

Long-term safety of UCART19 with or without alemtuzumab

* 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

Time frame: Up to 15 Year

Secondary Outcomes

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

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

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

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

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)

Proportion of patients with detectable UCART19 levels in bone marrow

Data from ClinicalTrials.gov

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