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Trial Title:
Long-term Follow-up of Participants Treated with Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies
NCT ID:
NCT06652633
Condition:
Hematological Malignancies
Conditions: Official terms:
Hematologic Neoplasms
Conditions: Keywords:
CAR T-cell therapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Genetic
Intervention name:
GLPG CAR T-cell therapy
Description:
No investigational products will be administered to participants in this study.
Arm group label:
Previously treated participants with GLPG CAR T-cell therapy
Summary:
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Antwerp University Hospital
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Universitaire (CHU) De Liège
Address:
City:
Liège
Zip:
4032
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Amsterdam UMC
Address:
City:
Amsterdam
Zip:
1081 HV
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Academisch Medisch Centrum
Address:
City:
Amsterdam
Zip:
1105 AZ
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Leids University Medical Center (LUMC)
Address:
City:
Leiden
Zip:
2333 ZA
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Hospital Clinic De Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Start date:
September 9, 2024
Completion date:
July 2039
Lead sponsor:
Agency:
Galapagos NV
Agency class:
Industry
Source:
Galapagos NV
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06652633
