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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02808442
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : July 21, 2020
Sponsor:
Collaborator:
ADIR, a Servier Group company
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

Study Description
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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).

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
Allocation: N/A
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 : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: UCART19 Biological: UCART19
Other Name: S68587


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and Severity of Adverse Events [ Time Frame: From inclusion to Month 12 ]
    Adverse events assessed according to NCI-CTCAE v5.0 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:   up 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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808442


Contacts
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Contact: Institut de Recherches Internationales Servier +33 1 55 72 43 66 clinical.trial.management@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 Withdrawn
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 Active, not recruiting
London, United Kingdom
Sponsors and Collaborators
Institut de Recherches Internationales Servier
ADIR, a Servier Group company
More Information
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Additional Information:

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Study Protocol  This link exits the ClinicalTrials.gov site
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Informed Consent Form  This link exits the ClinicalTrials.gov site
Clinical Study Report  This link exits the ClinicalTrials.gov site
Study-level clinical trial data  This link exits the ClinicalTrials.gov site

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Responsible Party: Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier: NCT02808442    
Other Study ID Numbers: UCART19_02 (CL1-68587-001)
2015-004293-15 ( EudraCT Number )
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
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: https://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
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases