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Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells

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: NCT03435796
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE January 9, 2018
First Posted Date  ICMJE February 19, 2018
Last Update Posted Date October 5, 2020
Actual Study Start Date  ICMJE June 19, 2018
Estimated Primary Completion Date November 30, 2032   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
  • Adverse Events (AEs) [ Time Frame: Up to 15 years from last GM T cell infusion ]
    Incidence of delayed Adverse Events suspected to be related to prior gene-modified (GM) T cell therapy
  • Tumor Response Status [ Time Frame: At month 12 from last GM T cells infusion then yearly until date of disease relapse or progression, assessed up to year 15 ]
    Number of subjects who continue to be responders, who have progressed, and who have relapsed will be reported. When reporting progression/relapse the appropriate date will also be reported.
  • Disease Progression [ Time Frame: Up to 15 years from last GM T cells infusion ]
    Number of subjects who continue to be responders, who have progressed, and who have relapsed will be reported. When reporting progression/relapse the appropriate date will also be reported.
  • Disease Relapse [ Time Frame: Up to 15 years from last GM T cells infusion ]
    Number of subjects who continue to be responders, who have progressed, and who have relapsed will be reported. When reporting progression/relapse the appropriate date will also be reported.
  • Overall Survival [ Time Frame: Up to 15 years from last GM T cells infusion ]
    Overall survival is defined as the time from the first dose of investigational product or from the randomization date to the date of death or the date the subject is last known to be alive.
  • Health-related quality of life (HRQoL) [ Time Frame: Up to approximately 5 years ]
    Health-related quality of life (HRQoL) analyses will be performed by combining data collected in this protocol with the data from each respective parent study as appropriate per parent study specified analysis plan, and per LTFU study plan after the parent study is closed out.
  • Height of pediatric subjects treated with GM T cells [ Time Frame: At month 12 from last GM T cells infusion then yearly until subject reaches Stage 5 per Tanner staging criteria or for 15 years from last GM T cell infusion, whichever occurs later ]
    Height (inches or centimeters) will be collected for all pediatric subjects and descriptively summarized
  • Weight of pediatric subjects treated with GM T cells [ Time Frame: At month 12 from last GM T cells infusion then yearly until subject reaches Stage 5 per Tanner staging criteria or for 15 years from last GM T cell infusion, whichever occurs later ]
    Weight (pounds or kilograms) will be collected for all pediatric subjects and descriptively summarized
  • Sexual maturation of pediatric subjects treated with GM T cells [ Time Frame: At month 12 from last GM T cells infusion then yearly until subject reaches Stage 5 per Tanner staging criteria or for 15 years from last GM T cell infusion, whichever occurs later ]
    Sexual maturation, assessed by Tanner staging system, will be conducted for all pediatric subjects and descriptively summarized
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
Official Title  ICMJE LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH CAR T CELLS
Brief Summary

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult subjects exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.

Subjects who received at least one GM T cell infusion, will be asked to roll-over to this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

Detailed Description

Subjects participating in this study will be followed from time of roll-over from the parent GM T protocol until 15 years after the last GMT infusion, withdrawal of consent, lost to follow-up, or death, whichever occurs first. Both local and central laboratory evaluations and safety assessments will be conducted during this trial. In addition, pediatric subjects will be monitored for growth, development and sexual maturity.

Stage 5 per Tanner Staging Criteria must be reached prior to study discontinuation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE Genetic: Gene-modified (GM) T cell therapy
Gene-modified (GM) T cell therapy
Study Arms  ICMJE Subjects exposed to Gene-modified (GM) T cell therapy
Subjects will be followed for 15 years from the last GM T cells infusion until withdrawal of consent, lost to follow-up, or death, whichever occurs first. Annual safety assessments will be conducted every 6 months during the first 5 years from the date of last GM T cell infusion. Laboratory evaluations and safety assessments will be conducted during this period. After 5 years, subjects will continue to be followed yearly. During the trial, pediatric subjects will be monitored for growth, development and sexual maturity. Stage 5 per Tanner Staging Criteria must be reached prior to study discontinuation.
Intervention: Genetic: Gene-modified (GM) T cell therapy
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: June 25, 2018)
191
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2018)
200
Estimated Study Completion Date  ICMJE November 30, 2032
Estimated Primary Completion Date November 30, 2032   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects who meet the following criteria will be eligible to participate in the Long-Term Follow-Up study:

  1. All adult and pediatric subjects who received at least one GM T cells infusion in a previous Celgene sponsored or Celgene alliance partner sponsored study, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.
  2. Subject (and, parental/legal representative, when applicable) must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.
  3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

Not Applicable

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com
Listed Location Countries  ICMJE Japan,   Austria,   Belgium,   Canada,   Finland,   France,   Germany,   Italy,   Netherlands,   Norway,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03435796
Other Study ID Numbers  ICMJE GC-LTFU-001
U1111-1206-8250 ( Registry Identifier: WHO )
2017-001465-24 ( 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 Not Provided
Responsible Party Celgene
Study Sponsor  ICMJE Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Claudia Schusterbauer, MD Celgene Corporation
PRS Account Celgene
Verification Date September 2020

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