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

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

Official Title
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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)

Conditions
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Advanced Lymphoid Leukemia

Intervention / Treatment
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* Biological: UCART19 follow-up


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UCART19 follow-up<br> | Biological: UCART19 follow-up<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 15 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of long-term anti tumor activity of UCART19 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |