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-GB
• Lead Sponsor: Celgene Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-17
• Last Update Posted: 23 November 2020

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 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.
2. Subject (and, parental/legal representative, when applicable) must understand and voluntarily sign an ICF/IAF prior to any study-related assessments/procedures being
conducted.
3. 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