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
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
Treatments tested in this trial
- Gene-modified (GM) T cell therapy
Treatment groups
1,541 Participants
are divided into 1 treatment groupLocations
205Australia
Royal Prince Alfred Hospital2050, CamperdownNew South Wales, Australia
Peter MacCallum Cancer Centre3000, MelbourneVictoria, Australia
The Alfred Hospital3004, MelbourneVictoria, Australia
Fiona Stanley Hospital6150, MurdochWestern Australia, Australia
Sponsors and collaborators
Celgene
Lead sponsor
Source ClinicalTrials.gov