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

  • End date
    Nov 30, 2036
  • participants needed
  • sponsor
Updated on 16 October 2022
treatment regimen


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 Neoplasms
Treatment Gene-modified (GM) T cell therapy
Clinical Study IdentifierNCT03435796
Last Modified on16 October 2022


Yes No Not Sure

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

Other protocol-defined inclusion/exclusion criteria apply
Not Applicable
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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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