Neuroblastoma, Osteosarcoma, Ewing sarcoma, Advanced breast cancer
Conditions
Brief summary
Percentage of patients with late-onset adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI) including relapse or progression of the underlying disease, life-threatening infections, death due to any cause, new and secondary malignancies
Detailed description
Pediatric patients: Height and weight, Tanner status, Percentage of patients who relapse or progress since enrollment and rate of surviving patients, Probabilities of overall survival, disease-free survival, Duration of response, relapse rate and time to relapse, Percentage of patients with detectable transgene levels. If results of 2 consecutive years are negative for an individual patient, further sampling will not be continued for this patient.
Interventions
DRUGGD2IL18CART
Sponsors
Universitaet Muenster
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with late-onset adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI) including relapse or progression of the underlying disease, life-threatening infections, death due to any cause, new and secondary malignancies | — |
Secondary
| Measure | Time frame |
|---|---|
| Pediatric patients: Height and weight, Tanner status, Percentage of patients who relapse or progress since enrollment and rate of surviving patients, Probabilities of overall survival, disease-free survival, Duration of response, relapse rate and time to relapse, Percentage of patients with detectable transgene levels. If results of 2 consecutive years are negative for an individual patient, further sampling will not be continued for this patient. | — |
Countries
Germany
Outcome results
None listed