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EUCTR2014-001673-14
Alternative entry: NCT02445222

Long term follow-up study for patients who have been treated withlentivirus-based chimeric antigen receptor (CAR) T-Cell Therapy

Data source: WHO (Imported from 18.10.2020)
Changed: 18.10.2020
Disease category:

Health conditions (Data source: WHO)

Patients who have received CAR T-cell therapy in the context of aNovartis and/or Penn treatment trial.
MedDRA version: 21.0Level: PTClassification code 10003917Term: B-cell type acute leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0Level: PTClassification code 10003899Term: B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Cancer [C04]

Interventions (Data source: WHO)


Product Name: CTL019
Product Code: CTL019
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: tisagenlecleucel-T (USAN)
Current Sponsor code: CTL019
Other descriptive name: AUTOLOGOUS T CELLS TRANSDUCED WITH LENTIVIRAL VECTOR CONTAINING A CHIMERIC ANTIGEN RECEPTOR DIRECTED AGAINST CD19
Concentration unit: Other
Concentration type: range
Concentration number: 100000000-500000000

Inclusion/Exclusion Criteria (Data source: WHO)

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 340
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 105

Exclusion criteria:
- There are no specific exclusion criteria for this study.

Further information on the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001673-14

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2014-001673-14-AT

Further information on trial

Date trial registered

07.07.2015

Incorporation of the first participant

06.10.2015

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Data source: WHO)

Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy - CD19 CART Long Term Follow Up (LTFU) study

Type of trial (Data source: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Data source: WHO)

Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no

Phase (Data source: WHO)

Human pharmacology (Phase I): yesTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): noTherapeutic use (Phase IV): no

Primary end point (Data source: WHO)

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

Secundary end point (Data source: WHO)

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

Contact information (Data source: WHO)

Novartis Pharma Services AG

Trial results (Data source: WHO)

Results summary

Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy

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)

Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Hong Kong, Italy, Japan, Korea, Netherlands, Norway, Republic of, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Contact for further information on the trial

Contact for general information (Data source: WHO)

Drug Regulatory Affairs
Jakov-Lind-Straße 5 / Top 3.05
Novartis Pharma GmbH
+43 186657 0
austria.dra@novartis.com

Contact for scientific information (Data source: WHO)

Drug Regulatory Affairs
Jakov-Lind-Straße 5 / Top 3.05
Novartis Pharma GmbH
+43 186657 0
austria.dra@novartis.com

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Novartis Pharma Services AG

Further trial identification numbers

Secondary ID (Data source: WHO)

CCTL019A2205B
NCT02445222