Study of UCART19 in Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia

Conditions

Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed B-cell Acute Lymphoblastic Leukemia

Brief summary

This study aims to evaluate the safety and feasibility of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).

Benjamin R, Graham C, Yallop D, Jozwik A, Mirci-Danicar OC, Lucchini G, Pinner D, Jain N, Kantarjian H, Boissel N, Maus MV, Frigault MJ, Baruchel A, Mohty M, Gianella-Borradori A, Binlich F, Balandraud S, Vitry F, Thomas E, Philippe A, Fouliard S, Dupouy S, Marchiq I, Almena-Carrasco M, Ferry N, Arnould S, Konto C, Veys P, Qasim W, UCART19 Group.

2020-12-01273 citations

10.1016/s0140-6736(20)32334-5

Preliminary Data on Safety, Cellular Kinetics and Anti-Leukemic Activity of UCART19, an Allogeneic Anti-CD19 CAR T-Cell Product, in a Pool of Adult and Pediatric Patients with High-Risk CD19+ Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

Reuben Benjamin, Charlotte Graham, Deborah Yallop, Agnieszka Jóźwik, Oana Ciocârlie et al. (26 authors)

Blood2018-11-2986 citations

10.1182/blood-2018-99-111356

Interventions

BIOLOGICALUCART19

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 17 Years

Healthy volunteers

No

Inclusion criteria

* Patient with relapsed or refractory CD19-positive B-acute lymphoblastic leukaemia (B-ALL) who have exhausted alternative treatment options. * Estimated life expectancy ≥ 12 weeks * Lansky (age \< 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at time of assent/consent) performance status ≥ 50

Exclusion criteria

* Burkitt leukemia * CD19-negative B-cell leukemia * Active Central Nervous System (CNS) leukemia * Active acute or chronic Graft-versus-Host Disease (GvHD) requiring systemic use therapy within 4 weeks before UCART19 infusion * Patients with autoimmune disease requiring systemic immunosuppression therapy that cannot be stopped * History of CRS grade 4 related to previous CAR T cell therapy * Contraindication to Alemtuzumab administration

Design outcomes

Primary

Measure	Time frame	Description
Incidence and Severity of Adverse Events	From inclusion to Month 12	Adverse events assessed according to NCI-CTCAE v5.0 criteria

Secondary

Measure	Time frame	Description
Molecular Remission Rate	At Day 28 after the first UCART19 infusion	Proportion of patients in whom a molecular Complete Remission (CR) or a Complete Remission with incomplete blood recovery (CRi) is observed (i.e. a CR or CRi combined to a Minimal residual disease \<10-4).

Countries

France, Spain, United Kingdom, United States

Outcome results

None listed