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Long-Term Follow-up Protocol for Participants 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 : April 20, 2023
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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Brief Summary:

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

Participants who received at least one GM T cell infusion will be asked to enroll in 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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 317 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : November 30, 2036
Estimated Study Completion Date : November 30, 2036

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Participants exposed to Gene-modified (GM) T cell therapy Genetic: Gene-modified (GM) T cell therapy
No investigational product will be administered


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of delayed Adverse Events (AEs) [ Time Frame: Up to 15 years from last gene-modified (GM) T cell infusion ]
  2. Persistence of GM T cells [ Time Frame: Up to 15 years from last GM T cell infusion ]
  3. Analysis of vector integration sites [ Time Frame: Up to 15 years from last GM T cell infusion ]
  4. Incidence of replication-competent lentiviruses [ Time Frame: Up to 15 years from last GM T cell infusion ]
  5. Physical growth as assessed by physical examination (pediatric participants only) [ Time Frame: Up to 15 years from last GM T cells infusion or until Tanner Stage 5 is reached ]
  6. Incidence of sexual maturation as assessed by the Tanner staging system (pediatric participants only) [ Time Frame: Up to 15 years from last GM T cells infusion or until Tanner Stage 5 ]
  7. Disease status of the primary malignancy [ Time Frame: Up to 15 years from last GM T cell infusion ]
  8. Disease Progression: Number of participants who continue to be responders, who have progressed, and who have relapsed will be reported. [ Time Frame: Up to 15 years from last GM T cells infusion ]
  9. Disease Relapse: Number of participants who continue to be responders, who have progressed, and who have relapsed will be reported. [ Time Frame: Up to 15 years from last GM T cells infusion ]
  10. Overall Survival 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 participant is last known to be alive. [ Time Frame: Up to 15 years from last GM T cells infusion ]

Secondary Outcome Measures :
  1. Lymphocyte count (B-cell) [ Time Frame: Up to 15 years ]
    If B-cell recovery criteria are not met at Month 60 (Year 5), then annual monitoring will continue until B-cell recovery is confirmed on 2 consecutive analyses or up to 15 years, until subject withdrawal of consent, or death, whichever occurs first.


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:

  • Received at least one gene-modified (GM) T-cell 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.
  • Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.

Exclusion Criteria:

Not Applicable

Other protocol-defined inclusion/exclusion criteria apply

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): NCT03435796


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

Locations
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Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03435796    
Other Study ID Numbers: GC-LTFU-001
U1111-1206-8250 ( Registry Identifier: WHO )
2017-001465-24 ( EudraCT Number )
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: April 20, 2023
Last Verified: April 2023

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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