Enrolling by invitation NCT06925685

Follow-Up for Study Participants Treated With an Allogeneic CAR T-Cell Product

— Observational Hematologic Malignancies Solid Tumors

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: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Hematologic Malignancies, Solid Tumors. 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
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Long Term Follow up Study for Participants Treated With an Allogeneic CAR T-Cell Product in a Prior Clinical Study

Overview

An observational, long-term follow up (LTFU) study of participants who received an allogeneic CAR T product in a prior clinical study. Participants will be followed for 15 years after their last infusion of an allogenic CAR T cell product.

Primary outcome measures

Incidence of delayed adverse events potentially related to allogeneic CAR T-cell product and allogeneic CAR T-cell product-related SAEs [Time frame: Up to 15 years post treatment with allogeneic CAR T-cell product]
Overall survival (OS) [Time frame: Up to 15 years post treatment with allogeneic CAR T cell product]
Presence of replication competent lentivirus (RCL) in blood [Time frame: Up to 15 years post treatment with allogeneic CAR T cell product]

Eligibility criteria

Inclusion criteria

Received an allogenic CAR T-cell product infusion to treat an oncologic condition in a previous Allogene or Servier sponsored clinical study

Exclusion criteria

Less than 12 months of follow up after the last allogeneic CAR T-cell product, unless approved by the Allogene Medical Monitor

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

Healthy volunteers: No

Study design

Observational model: Case-only

Study locations

United States · 1 center

Circuit Clinical — Buffalo

Identifiers

NCT: NCT06925685 · ALLO-LTFU-101

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗