Study of UCART19 in Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia (PALL)
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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 : October 25, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Refractory B-cell Acute Lymphoblastic Leukemia Relapsed B-cell Acute Lymphoblastic Leukemia | Biological: UCART19 | Phase 1 |
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 : | July 2020 |
Estimated Study Completion Date : | July 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: UCART19 |
Biological: UCART19
Other Name: S68587 |
- Incidence and Severity of Adverse Events [ Time Frame: From inclusion to Month 12 ]Adverse events assessed according to NCI-CTCAE v5.0 criteria
- 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).

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Ages Eligible for Study: | up to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts 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

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
Contact: Institut de Recherches Internationales Servier | +33 1 55 72 43 66 | clinicaltrials@servier.com |
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 |
Additional Information:
Study Data/Documents: Individual Participant Data Set

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 Key Record Dates |
Last Update Posted: | October 25, 2019 |
Last Verified: | October 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:
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/ |
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 |
Burkitt Lymphoma Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid 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 |