LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH GENE-MODIFIED T CELLS

LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH GENE-MODIFIED T CELLS - GC-LTFU-001 (0451/0266)

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54564

Enrollment

Registered

2018-02-02

Start date

2022-01-15

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

related to parent study bb2121-MM-003: blood and lymphatic system disorders -->plasma cell neoplasms

Interventions

None listed

Eligibility

Age

No minimum to 99 Years

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Overview of Key Safety Assessments For all subjects will include, a brief clinical history and physical examination, screening for the emergence of potentially delayed AEs, and onset of new clinical conditions following exposure to GM T cells, including neurologic disorders, hematologic disorders, rheumatic and autoimmune disorders, or exacerbation of one of these pre--existing conditions. or occurrence of a second primary malignancy (SPM; hematologic or solid). For pediatric subjects, growth and sexual maturation will also be asses sed. Overview of Key Efficacy Assessments No study specific disease assessments will be conducted for the purposes of this trial. However, disease status will be collected for subjects who have not progressed in the parent treatment protocol. Overview of Key HRQoL Assessments Whenever applicable, subjects will be followed for the first 5 years from the date of the last GM T-cell infusion for HRQoL. Collection of the PRO instruments conducted in the parent treatment protocol will continue to be completed in the LTFU protocol. For subjects that do not complete the questionnaires at any given point, reasons for not collecting will be reported.	—

Measure

Time frame

Overview of Key Safety Assessments For all subjects will include, a brief clinical history and physical examination, screening for the emergence of potentially delayed AEs, and onset of new clinical conditions following exposure to GM T cells, including neurologic disorders, hematologic disorders, rheumatic and autoimmune disorders, or exacerbation of one of these pre--existing conditions. or occurrence of a second primary malignancy (SPM; hematologic or solid). For pediatric subjects, growth and sexual maturation will also be asses sed. Overview of Key Efficacy Assessments No study specific disease assessments will be conducted for the purposes of this trial. However, disease status will be collected for subjects who have not progressed in the parent treatment protocol. Overview of Key HRQoL Assessments Whenever applicable, subjects will be followed for the first 5 years from the date of the last GM T-cell infusion for HRQoL. Collection of the PRO instruments conducted in the parent treatment protocol will continue to be completed in the LTFU protocol. For subjects that do not complete the questionnaires at any given point, reasons for not collecting will be reported.

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Secondary

Measure	Time frame
To assess long-term health-related quality-of-life following treatment with GM T-cells	—

Countries

Netherlands

Outcome results