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A Study to Evaluate the Long-term Safety of Patients With Advanced Lymphoid Malignancies Who Have Been Previously Administered With UCART19

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02735083
Recruitment Status : Enrolling by invitation
First Posted : April 12, 2016
Last Update Posted : October 19, 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:
The purpose of this study is to evaluate the long-term safety and efficacy of UCART19 administration to patients with advanced lymphoid malignancies.

Condition or disease Intervention/treatment Phase
Advanced Lymphoid Malignancies Biological: UCART19 follow-up Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Long-term Follow-up Study of Patients Who Have Previously Been Exposed to UCART19 (Allogeneic Engineered T-cells Expressing a Lentiviral-based Anti-CD19 Chimeric Antigen Receptor)
Actual Study Start Date : November 9, 2016
Estimated Primary Completion Date : March 2040
Estimated Study Completion Date : March 2040
Arms and Interventions
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Arm Intervention/treatment
Experimental: UCART19 follow-up Biological: UCART19 follow-up
UCART19 will not be administered during the study period. Patients who will be rolled-over from the parent study to this long term follow-up study, have previously received UCART19. The roll-over occurs at the end of the parent study, or at any time after UCART19 administration, in case of premature discontinuation from the parent study.


Outcome Measures
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Primary Outcome Measures :
  1. Long-term safety of UCART19 with or without alemtuzumab [ Time Frame: Up to 15 Year ]
    • Number, duration, outcome of all adverse events (AE) within 12 months post last UCART19 infusion
    • Number, duration, outcome of adverse events of special interest (AESI) up to the end of the study
    • Proportion of patients with adverse events leading to death up to the end of the study
    • For paediatric patients: assesment of the potential impact on growth curve and puberty


Secondary Outcome Measures :
  1. Assessment of long-term anti tumor activity of UCART19 [ Time Frame: Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing then every 6 months up to Year 3, then yearly up to Year 15 ]
  2. Proportion of patients who underwent allogeneic HSCT (Hematopoietic Stem Cell Transplantation) for patients treated with UCART19 [ Time Frame: Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15 ]
  3. Time to transplant for patients treated with UCART19 [ Time Frame: Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15 ]
  4. Assessment of overall survival [ Time Frame: Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15 ]
  5. Proportion of patients with detectable UCART19 levels in blood [ Time Frame: Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15 ]
  6. Proportion of patients with detectable UCART19 levels in bone marrow [ Time Frame: Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent obtained prior any study-specific procedure (patient or parent(s) or legal representative)
  • Patient dosed with UCART19 who completed or discontinued early from a sponsored or from any investigator-initiated study that tested UCART19, or patients who were administered UCART19 under a special access scheme (compassionate use);
  • Female patients of childbearing potential and male patients with partners of childbearing potential must continue to use an effective method of birth control as well as their partners for a 12-month duration after the last UCART19 administration.

Exclusion Criteria:

- No exclusion criteria for this study

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): NCT02735083


Locations
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United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
United States, Colorado
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80219
United States, Florida
Moffit Cancer Center
Tampa, Florida, United States, 33612
United States, Massachusetts
Massachussetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
France
Hôpital Saint-Antoine
PARIS Cedex 12, France, 75571
Hôpital Saint-Louis
Paris, France, 75010
Hôpital Robert-Debré
Paris, France, 75019
Japan
Kyushyu University Hospital
Fukuoka, Japan, 812-8582
Hokkaido University Hospital
Sapporo, Japan, 060-8648
Spain
Hospital San Juan De Dios
Barcelona, Spain, 08950
United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
UCL Great Ormond Hospital
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Institut de Recherches Internationales Servier
ADIR, a Servier Group company
Investigators
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Principal Investigator: Reuben Benjamin, MD, PhD King's College Hospital NHS Trust
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: NCT02735083    
Other Study ID Numbers: CL1-68587-003
2016-000297-38 ( EudraCT Number )
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

  • used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

  • sponsored by Servier
  • with a first patient enrolled as of 1 January 2004 onwards
  • for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
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
Additional relevant MeSH terms:
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Neoplasms