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

Celgene

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Neoplasms

Treatments: Genetic: Gene-modified (GM) T cell therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03435796

U1111-1206-8250 (Registry Identifier)

2017-001465-24 (EudraCT Number)

GC-LTFU-001

Details and patient eligibility

About

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.

Enrollment: 317 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Not Applicable

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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317 participants in 1 patient group

Participants exposed to Gene-modified (GM) T cell therapy

Other group

Treatment:

Genetic: Gene-modified (GM) T cell therapy