ong-Term Follow-up Protocol for Subjects Treated with Gene-Modified T cells.

Phase 1

• Conditions: Defined by parent protocol. The study will enroll all adult and paediatric subjects who received at least one genetically modified T cells infusion in a previous Celgene sponsored study.; MedDRA version: 21.0Level: LLTClassification code 10025631Term: Malignant lymphoid neoplasm NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-001465-24-FI
• Lead Sponsor: Celgene Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-18
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 525

Inclusion Criteria

1. All adult and pediatric subjects who received at least one 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.

2. Subject (and, parental/legal representative, when applicable) must understand and voluntarily sign an Informed Consent Form (ICF) / Informed Assent Form (IAF) prior to any study-related assessments/procedures being conducted.

3. Not applicable per Protocol Amendment 01: Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
Are the trial subjects under 18? yes
Number of subjects for this age range: 91
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 238
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 196

Exclusion Criteria

Not Applicable.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified