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

Relapsed B-cell Acute Lymphoblastic Leukemia Clinical Trial

— PALL  

Official title:

A Phase 1, Open Label, Non-comparative Study to Evaluate the Safety and the Ability of UCART19 to Induce Molecular Remission in Paediatric Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808442
• Other study ID #: UCART19_02 (CL1-68587-001)
• Secondary ID: 2015-004293-15
• Status: Completed
• Phase: Phase 1
• Start date: June 3, 2016
• Est. completion date: November 4, 2020

Study information

• Verified date: September 2021
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 4, 2020
• Est. primary completion date: September 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Refractory B-cell Acute Lymphoblastic Leukemia
• Relapsed B-cell Acute Lymphoblastic Leukemia

Intervention

Biological:
• UCART19

Locations

Country	Name	City	State
France	Hôpital Robert-Debré	Paris
Spain	Hospital San Juan De Dios	Barcelona
United Kingdom	UCL Great Ormond Hospital	London
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier	ADIR, a Servier Group company

Countries where clinical trial is conducted

United States,  France,  Spain,  United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and Severity of Adverse Events	Adverse events assessed according to NCI-CTCAE v5.0 criteria	From inclusion to Month 12
Secondary	Molecular Remission Rate	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).	At Day 28 after the first UCART19 infusion

External Links

•   Lay Summary
•   Results Summary