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

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ClinicalTrials.gov Identifier: NCT03435796
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

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.


Condition or disease Intervention/treatment Phase
Neoplasms Genetic: Gene-modified (GM) T cell therapy Phase 2 Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 191 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH CAR T CELLS
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : November 30, 2032
Estimated Study Completion Date : November 30, 2032

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Genetic: Gene-modified (GM) T cell therapy
Gene-modified (GM) T cell therapy




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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



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

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:


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): NCT03435796


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-7680
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Icahn School of Medicine at Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
United States, Tennessee
Sarah Cannon Research Institute Center for Blood Cancers Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75235
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Belgium
Universitaire Ziekenhuizen Leuven-Campus Gasthuisberg Recruiting
Leuven, Belgium, 3000
Germany
University of Tubingen Recruiting
Tübingen, Germany, 72076
Japan
National Cancer Center Hospital Recruiting
Chuo-ku, Japan, 104-0045
Spain
Hospital Universitari Germans Trias i Pujol Can Ruti Recruiting
Badalona, Spain, 08916
Clínica Universidad de Navarra Recruiting
Pamplona, Spain, 31088
Sponsors and Collaborators
Celgene
Investigators
Study Director: Claudia Schusterbauer, MD Celgene Corporation

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03435796     History of Changes
Other Study ID Numbers: GC-LTFU-001
U1111-1206-8250 ( Registry Identifier: WHO )
2017-001465-24 ( EudraCT Number )
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celgene:
Long-term follow up
Gene-Modified T Cells
CAR T Cell