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Recruiting Phase 2, Phase 3 NCT03435796

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

Trial Parameters

Condition Neoplasms
Sponsor Celgene
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 1,541
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2018-07-19
Completion 2036-11-30
Interventions
Gene-modified (GM) T cell therapy

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 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

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

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