Health Trials

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

ConditionNeoplasms
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCelgene

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Gene-modified (GM) T cell therapy

    Genetic

    No investigational product will be administered

Treatment groups

1,541 Participants
are divided into 1 treatment group
Group A: Participants exposed to Gene-modified (GM) T cell therapyOther 1 intervention

Trial outcomes

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

Secondary outcomes

1

Lymphocyte count (B-cell)

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.

Time frame
Up to 15 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Celgene

Lead sponsor

Source ClinicalTrials.gov
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