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NCT Number: NCT03435796

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

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 infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

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Key information

Conditions

Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored, Juno Therapeutics, other affiliates of BMS, or Celgene alliance partner-sponsored trial, 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

Treatment and study plan

Gene-modified (GM) T cell therapy

Genetic

No investigational product will be administered

Primary outcomes

  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 cell drug products

    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. Proportion of participants who progressed on the study: participants with original diagnosis of malignancies

    Time frame: Up to 15 years from last GM T cells infusion

  8. Overall Survival (participants with original diagnosis of malignancies)

    Time frame: Up to 15 years from last GM T cells infusion

Secondary outcomes

  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 up to 15 years, until subject withdrawal of consent, or death, whichever occurs first.

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Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2043
Study completion
2043
First posted
Feb 19, 2018
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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