All patients who have been treated with chimeric antigen receptor (CAR) T-cell therapy in the context of a prior Novartis sponsored or supported study for any indication. MedDRA version: 21.0 Level: PT Classification code 10003917 Term: B-cell type acute leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10003899 Term: B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, mal
Conditions
Interventions
Trade Name: Kymriah
Note:
No investigational treatment (no IMP) is foreseen within this study.
This study is a long term follow-up study for patients exposed to lentiviral-based CAR T-cell therapy in
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients must have received CAR-T therapy within one of the following: • Novartis or Penn sponsored CAR-T treatment trials where CAR-T was given as monotherapy or as combination therapy. • Novartis managed access programs outside of the commercial setting, i.e. where CAR-T therapy was intended to be given in the setting of a Novartis or Penn sponsored CAR-T treatment trial 2.Patients must provide informed consent prior to their entry into this study. Are the trial subjects under 18? yes Number of subjects for this age range: 255 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 472 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 173
Exclusion criteria
Exclusion criteria: - There are no specific exclusion criteria for this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Proportion of patients with detectable CAR transgene levels in peripheral blood by q-PCR at pre-specified time points 2- Proportion of patients with detectable RCL by VSV-G q-PCR in peripheral blood at pre-specified time points 3- Proportion of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry and Incidence of death 4- B and T lymphocyte count 5-Height and weight, Tanner staging, menstruation status;Timepoint(s) of evaluation of this end point: as defined per protocol | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to monitor all patients exposed to CAR Tcells (CAR-T) for 15 years following last CAR-T (e.g.CTL019) infusion to assess the risk of delayed adverse events (AEs) and assess long term efficacy, including vector persistence. Primary objective is: to describe selected, delayed AEs that are suspected to be related to previous CAR T-cell therapy as outlined in current Health Authority guidelines;Secondary Objective: 1 • Monitor the persistence of modified T-cells in peripheral blood 2 • Monitor for RCL (Replication Competent Lentivirus) 3 • Assess the long-term efficacy of CAR-T 4 • Monitor lymphocyte levels 5 • Describe the growth, development, and female reproductive status for patients who were aged < 18 years at the time of the initial CAR-T infusion;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: as defined per protocol | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Netherlands, Norway, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactDrug Regulatory Affairs
Novartis Pharma GmbH
Outcome results
None listed