Advanced Lymphoid Leukemia
Conditions
Brief summary
The purpose of this study is to evaluate the long-term safety and efficacy of UCART19 administration to patients with advanced lymphoid leukemia.
Interventions
BIOLOGICALUCART19 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.
Sponsors
ADIR, a Servier Group company
Institut de Recherches Internationales Servier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 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 |
| 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 |
Countries
France, Japan, Spain, United Kingdom, United States
Outcome results
None listed