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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

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 )

Tracking Information
First Submitted Date  ICMJE March 14, 2016
First Posted Date  ICMJE April 12, 2016
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE November 9, 2016
Estimated Primary Completion Date March 2040   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
Long-term safety of UCART19 [ Time Frame: Up to 15 Year ]
- Adverse events assessed as related to UCART19
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2020)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
  • Assessment of long-term anti leukemic activity of UCART19. [ Time Frame: onth 3, Month 6, Month 12 during Year 1 following UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15 if the follow-up period is prolonged ]
  • Proportion of patients who underwent allogeneic HSCT (Hematopoietic Stem Cell Transplantation) [ Time Frame: Month 3, Month 6, Month 12 during Year 1 following UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15 if the follow-up period is prolonged ]
  • -Proportion of patients with detectable UCART19 levels in peripheral blood [ Time Frame: Month 3, Month 6, Month 12 during Year 1 following UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15 if the follow-up period is prolonged ]
  • Time to transplant [ Time Frame: Month 3, Month 6, Month 12 during Year 1 following UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15 if the follow-up period is prolonged ]
  • Proportion of patients with detectable RCL (Replication Competent Lentivirus) in peripheral blood [ Time Frame: Month 3, Month 6, Month 12 during Year 1 following UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15 if the follow-up period is prolonged ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Long-term Safety of Patients With Advanced Lymphoid Malignancies Who Have Been Previously Administered With UCART19
Official Title  ICMJE 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)
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.
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: Other
Condition  ICMJE Advanced Lymphoid Malignancies
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: UCART19 follow-up
Intervention: Biological: UCART19 follow-up
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 Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 10, 2019)
300
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2016)
200
Estimated Study Completion Date  ICMJE March 2040
Estimated Primary Completion Date March 2040   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Japan,   Spain,   United Kingdom,   United States
Removed Location Countries Belgium
 
Administrative Information
NCT Number  ICMJE NCT02735083
Other Study ID Numbers  ICMJE CL1-68587-003
2016-000297-38 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
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
Principal Investigator: Reuben Benjamin, MD, PhD King's College Hospital NHS Trust
PRS Account Servier
Verification Date October 2020

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