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

• Sponsor: Institut de Recherches Internationales Servier
• Collaborator: ADIR, a Servier Group company
• Information provided by (Responsible Party): Servier ( Institut de Recherches Internationales Servier )

Study Description

Brief Summary:

This study aims at evaluating 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).

Condition or disease	Intervention/treatment	Phase
Refractory B-cell Acute Lymphoblastic Leukemia; Relapsed B-cell Acute Lymphoblastic Leukemia	Biological: UCART19	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	18 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Actual Study Start Date :	June 3, 2016
Estimated Primary Completion Date :	April 2020
Estimated Study Completion Date :	April 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: UCART19	Biological: UCART19; Other Name: S68587

Outcome Measures

Primary Outcome Measures :

1. Incidence and Severity of Adverse Events [ Time Frame: From inclusion to Month 12 ]
   Adverse events assessed according to NCI-CTCAE v4.03 criteria

Secondary Outcome Measures :

1. Molecular Remission Rate [ Time Frame: 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).

Eligibility Criteria

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Ages Eligible for Study:	6 Months to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Contacts

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Contact: Institut de Recherches Internationales Servier	+33 1 55 72 43 66	clinicaltrials@servier.com

Locations

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United States, California
Children's Hospital Los Angeles	Recruiting
Los Angeles, California, United States, 90027
United States, Pennsylvania
Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Southwestern Medical Center	Recruiting
Dallas, Texas, United States, 75390
Belgium
Het Kinderziekenhuis Prinses Elisabeth - UZG	Recruiting
Gent, Belgium, 9000
France
Hôpital Robert-Debré	Recruiting
Paris, France, 75019
Spain
Hospital San Juan De Dios	Recruiting
Barcelona, Spain, 08950
United Kingdom
UCL Great Ormond Hospital	Recruiting
London, United Kingdom

Sponsors and Collaborators

Institut de Recherches Internationales Servier

ADIR, a Servier Group company

More Information

Additional Information:

Find Results on Servier Clinical Trial Data 

Study Data/Documents: Individual Participant Data Set 

Study Protocol 

Statistical Analysis Plan 

Informed Consent Form 

Clinical Study Report 

Study-level clinical trial data 

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Responsible Party:	Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier:	NCT02808442 History of Changes
Other Study ID Numbers:	UCART19_02 (CL1-68587-001); 2015-004293-15 ( EudraCT Number )
First Posted:	June 21, 2016
Last Update Posted:	May 9, 2019
Last Verified:	May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs). They can ask all interventional clinical studies: submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).; Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
Supporting Materials:	Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
Time Frame:	After Marketing Authorisation in EEA or US if the study is used for the approval.
Access Criteria:	Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
URL:	http://clinicaltrials.servier.com/

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Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No
Product Manufactured in and Exported from the U.S.:		No

Additional relevant MeSH terms:

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Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Burkitt Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders	Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma