All patients who have been treated with Novartis or Penn CAR-T for any indication
Conditions
Brief summary
Proportion of patients with events in each of the following categories: • New secondary malignancies • New serious infections, • New incidence of serious neurologic disorder, • New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, • New incidence of a hematologic disorder • Other adverse events considered related to CAR T cell therapy
Detailed description
Proportion of patients with detectable CAR transgene levels in peripheral blood by q-PCR at pre-specified time points, Proportion of patients with detectable RCL by VSV-G q-PCR in peripheral blood at pre-specified time points, • Proportion of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry • Incidence of death, B and T lymphocyte count, Height and weight, Tanner staging, menstruation status
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with events in each of the following categories: • New secondary malignancies • New serious infections, • New incidence of serious neurologic disorder, • New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, • New incidence of a hematologic disorder • Other adverse events considered related to CAR T cell therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with detectable CAR transgene levels in peripheral blood by q-PCR at pre-specified time points, Proportion of patients with detectable RCL by VSV-G q-PCR in peripheral blood at pre-specified time points, • Proportion of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry • Incidence of death, B and T lymphocyte count, Height and weight, Tanner staging, menstruation status | — |
Countries
Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Spain, Sweden
Outcome results
None listed