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Trial record 1 of 1 for:    PALL UCART19
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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 )

Tracking Information
First Submitted Date  ICMJE June 16, 2016
First Posted Date  ICMJE June 21, 2016
Last Update Posted Date July 21, 2020
Actual Study Start Date  ICMJE June 3, 2016
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
Incidence and Severity of Adverse Events [ Time Frame: From inclusion to Month 12 ]
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2016)
  • Incidence and Severity of Adverse Events [ Time Frame: From inclusion to Day 84 post UCART19 infusion or until the initiation of allo-HSCT conditioning regimen ]
    Adverse events assessed according to NCI-CTCAE v4.0 criteria
  • Incidence and Severity of Adverse Events [ Time Frame: From Day 85 or the initiation of allo-HSCT conditioning regimen to Month 15 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2016)
Molecular Remission Rate [ Time Frame: At Day 28 post UCART19 infusion ]
Proportion of patients in whom a Molecular Remission, as defined by National Comprehensive Cancer Network (NCCN) guideline, will be achieved
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of UCART19 in Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Refractory B-cell Acute Lymphoblastic Leukemia
  • Relapsed B-cell Acute Lymphoblastic Leukemia
Intervention  ICMJE Biological: UCART19
Other Name: S68587
Study Arms  ICMJE Experimental: UCART19
Intervention: Biological: UCART19
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 17, 2020)
18
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2016)
10
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Institut de Recherches Internationales Servier +33 1 55 72 43 66 clinical.trial.management@servier.com
Listed Location Countries  ICMJE Belgium,   France,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02808442
Other Study ID Numbers  ICMJE UCART19_02 (CL1-68587-001)
2015-004293-15 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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/
Responsible Party Servier ( Institut de Recherches Internationales Servier )
Study Sponsor  ICMJE Institut de Recherches Internationales Servier
Collaborators  ICMJE ADIR, a Servier Group company
Investigators  ICMJE Not Provided
PRS Account Servier
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP