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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-510173-34-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Previously treated participants with GLPG CAR T-cell therapy | Experimental | All participants who have been treated with a Galapagos CAR T-cell therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG CAR T-cell therapy | Genetic | No investigational products will be administered to participants in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with targeted adverse events (AEs) | From infusion up to 15 years | |
| Percentage of participants with detectable CAR transgene levels in peripheral blood | From infusion up to 15 years | |
| Percentage of participants with serious AEs (SAEs) considered related to the Galapagos CAR T-cell therapy | From infusion up to 15 years | |
| Percentage of participants with at least 1% of T-cells in the blood sample or positive new malignancies | From infusion up to 15 years | |
| Percentage of participants with detectable replication-competent lentivirus (RCL) in peripheral blood | From infusion up to 15 years | |
| Percentage of participants who died with causes | From infusion up to 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with disease progression | From infusion up to 15 years | |
| Time to subsequent anticancer therapy | From infusion up to 15 years | |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lakefront Biotherapeutics Medical Information | Contact | +3215342900 | medicalinfo@lakefrontbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Lakefront Biotherapeutics Study Director | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Recruiting | Boston | Massachusetts | 02111 | United States | |
| Antwerp University Hospital |
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| From infusion up to 15 years |
| Recruiting |
| Edegem |
| 2650 |
| Belgium |
| Universitair Ziekenhuis Leuven | Recruiting | Leuven | 3000 | Belgium |
| Centre Hospitalier Universitaire (CHU) De Liège | Recruiting | Liège | 4032 | Belgium |
| Algemeen Ziekenhuis Delta | Recruiting | Roeselare | 8800 | Belgium |
| Cliniques Universitaires Saint-Luc | Recruiting | Woluwe-Saint-Lambert | 1200 | Belgium |
| helsingin yliopistollinen sairaala comprehensive cancer center (HUS) | Not yet recruiting | Helsinki | 00290 | Finland |
| Academisch Medisch Centrum (Amsterdam UMC) | Recruiting | Amsterdam | 1105 AZ | Netherlands |
| Leids University Medical Center (LUMC) | Recruiting | Leiden | 2333 ZA | Netherlands |
| Erasmus Medisch Centrum | Not yet recruiting | Rotterdam | 3015 | Netherlands |
| Hospital Clinic De Barcelona | Recruiting | Barcelona | 08036 | Spain |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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