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Trial record 1 of 1 for:    CL1-68587-003
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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/ALLO-501

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ClinicalTrials.gov Identifier: NCT02735083
Recruitment Status : Enrolling by invitation
First Posted : April 12, 2016
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
ADIR, a Servier Group company
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

Brief Summary:
The purpose of this study is to evaluate the long-term safety and efficacy of UCART19/ALLO-501 administration to patients with advanced lymphoid malignancies.

Condition or disease Intervention/treatment Phase
Advanced Lymphoid Malignancies Biological: UCART19/ALLO-501 follow-up Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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/ALLO-501 (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

Arm Intervention/treatment
Experimental: UCART19/ALLO-501 follow-up Biological: UCART19/ALLO-501 follow-up
UCART19/ALLO-501 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/ALLO-501 but also a lymphodepletion regimen with: fludarabine and cyclophosphamide with or without alemtuzumab or ALLO-647. The roll-over occurs at the end of the parent study, or at any time after UCART19/ALLO-501 administration, in case of premature discontinuation from the parent study.




Primary Outcome Measures :
  1. Long-term safety of UCART19/ALLO-501 with or without alemtuzumab or ALLO-647 [ Time Frame: Up to 15 Year ]
    • Number, duration, outcome of all adverse events (AE) within 12 months post last UCART19/ALLO-501 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/ALLO-501. [ Time Frame: Month 3, Month 6, Month 12 during Year 1 following last UCART19/ALLO-501 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/ALLO-501 dosing, then every 6 months up to Year 3, then yearly up to Year 15 ]
  5. Proportion of patients with detectable UCART19/ALLO-501 levels in blood [ Time Frame: Month 3, Month 6, Month 12 during Year 1 following last UCART19/ALLO-501 dosing, then every 6 months up to Year 3, then yearly up to Year 15 ]
  6. Proportion of patients with detectable UCART19/ALLO-501 levels in bone marrow [ Time Frame: Month 3, Month 6, Month 12 during Year 1 following last UCART19/ALLO-501 dosing, then every 6 months up to Year 3, then yearly up to Year 15 ]
  7. Evaluation of immunogenicity against ALLO-647 in patients who have received ALLO-647 [ Time Frame: Month 3, Month 6 during Year 1 following last UCART19/ALLO-501 dosing ]


Information from the National Library of Medicine

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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/ALLO-501 who completed or discontinued early from a sponsored or from any investigator-initiated study that tested UCART19/ALLO-501, or patients who were administered UCART19/ALLO-501 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.

Exclusion Criteria:

- No exclusion criteria for this study


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, Massachusetts
Massachussetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Belgium
Het Kinderziekenhuis Prinses Elisabeth - UZG
Gent, Belgium, 9000
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

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

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Responsible Party: Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier: NCT02735083     History of Changes
Other Study ID Numbers: CL1-68587-003
2016-000297-38 ( EudraCT Number )
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 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: 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
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs