Recruiting NCT03435796

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

Phase II / Phase III Interventional Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Gene-modified (GM) T cell therapy.
Who it may be relevant to: Registry conditions: Neoplasms. Basic parameters: No limits · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Austria, Belgium, Canada +15
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

Genetic Gene-modified (GM) T cell therapy
No investigational product will be administered

Primary outcome measures

Incidence of delayed Adverse Events (AEs) [Time frame: Up to 15 years from last gene-modified (GM) T cell infusion]
Persistence of GM T cell drug products [Time frame: Up to 15 years from last GM T cell infusion]
Analysis of vector integration sites [Time frame: Up to 15 years from last GM T cell infusion]
Incidence of replication-competent lentiviruses [Time frame: Up to 15 years from last GM T cell infusion]
Physical growth as assessed by physical examination (pediatric participants only) [Time frame: Up to 15 years from last GM T cells infusion or until Tanner Stage 5 is reached]
Incidence of sexual maturation as assessed by the Tanner staging system (pediatric participants only) [Time frame: Up to 15 years from last GM T cells infusion or until Tanner Stage 5]
Proportion of participants who progressed on the study: participants with original diagnosis of malignancies [Time frame: Up to 15 years from last GM T cells infusion]
Overall Survival (participants with original diagnosis of malignancies) [Time frame: Up to 15 years from last GM T cells infusion]

Secondary outcome measures (1)

Lymphocyte count (B-cell) [Time frame: Up to 15 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Other