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Recruiting NCT06652633

Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies

Phase III Interventional Hematological Malignancies

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: GLPG CAR T-cell therapy.
Who it may be relevant to
Registry conditions: Hematological Malignancies. Basic parameters: from 18 years · 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, Belgium, Finland, Netherlands, Spain
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

A Long-term Follow-up Study for Patients Treated With Galapagos CAR T-cell Therapies

Overview

This is a long-term follow-up study for participants treated with Galapagos (GLPG) CAR T-cell therapies to evaluate the long-term safety and efficacy of GLPG CAR T-cell products for 15 years post infusion. Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all participants exposed to GLPG CAR T-cell therapies for 15 years following their last CAR T-cell infusion to assess the risk of delayed adverse events (AEs) and the long-term benefit/risk profile and to monitor for replication-competent lentivirus (RCL) and CAR-T cell persistence.

Interventions

  • Genetic GLPG CAR T-cell therapy
    No investigational products will be administered to participants in this study.

Primary outcome measures

  • Percentage of participants with targeted adverse events (AEs) [Time frame: From infusion up to 15 years]
  • Percentage of participants with detectable CAR transgene levels in peripheral blood [Time frame: From infusion up to 15 years]
  • Percentage of participants with serious AEs (SAEs) considered related to the Galapagos CAR T-cell therapy [Time frame: From infusion up to 15 years]
  • Percentage of participants with at least 1% of T-cells in the blood sample or positive new malignancies [Time frame: From infusion up to 15 years]
  • Percentage of participants with detectable replication-competent lentivirus (RCL) in peripheral blood [Time frame: From infusion up to 15 years]
  • Percentage of participants who died with causes [Time frame: From infusion up to 15 years]
Secondary outcome measures (3)
  • Percentage of participants with disease progression [Time frame: From infusion up to 15 years]
  • Time to subsequent anticancer therapy [Time frame: From infusion up to 15 years]
  • Overall survival [Time frame: From infusion up to 15 years]

Eligibility criteria

Inclusion criteria

  • All participants who have been treated with a Galapagos CAR T-cell therapy in a clinical trial or Managed Access Program.

Exclusion criteria

  • There are no exclusion criteria for this study

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

Study locations

Belgium · 5 centers
  • Antwerp University Hospital — Edegem
  • Universitair Ziekenhuis Leuven — Leuven
  • Centre Hospitalier Universitaire (CHU) De Liège — Liège
  • Algemeen Ziekenhuis Delta — Roeselare
  • Cliniques Universitaires Saint-Luc — Woluwe-Saint-Lambert
Netherlands · 3 centers
  • Academisch Medisch Centrum (Amsterdam UMC) — Amsterdam
  • Leids University Medical Center (LUMC) — Leiden
  • Erasmus Medisch Centrum — Rotterdam
United States · 1 center
  • Tufts Medical Center — Boston
Finland · 1 center
  • helsingin yliopistollinen sairaala comprehensive cancer center (HUS) — Helsinki
Spain · 1 center
  • Hospital Clinic De Barcelona — Barcelona

Identifiers

NCT: NCT06652633 · LTF-CL-001 · 2023-510173-34-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗