Health conditions
(Data source: WHO)
Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
Interventions (Data source: WHO)
Genetic: Previously treated CAR-T patients
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- All patients who have received a CAR-T therapy and completed or discontinued early
from a Novartis sponsored treatment protocol that utilized CAR-T cells or from any
CAR-T trial sponsored by the University of Pennsylvania with which Novartis has a
contractual agreement to co-develop the CAR technology.
- Patients who have provided informed consent for the long term follow up study prior to
their study participation .
Exclusion Criteria:
- There are no specific exclusion criteria for this study.
-
Further information on trial
Date trial registered
May 1, 2015
Incorporation of the first participant
Nov 2, 2015
Recruitment status
Recruiting
Academic title
(Data source: WHO)
Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
Percentage of patients with certain events (see description)
Secundary end point
(Data source: WHO)
Percentage of patients with detectable CAR transgene levels in peripheral blood by q-PCR at pre- specified time points;Percentage of patients with detectable RCL by VSV-G;Percentage 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
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Countries
(Data source: WHO)
Switzerland might not appear as site of trial if it has not yet been entered as such in the WHO primary registry.
Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Singapore, Spain, Taiwan, United Kingdom, United States
Contact for further information on the trial
Contact for general information
(Data source: WHO)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
1-888-669-6682
Contact for scientific information
(Data source: WHO)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
1-888-669-6682
Further trial identification numbers
Secondary ID (Data source: WHO)
2014-001673-14
CCTL019A2205B
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