Health TrialsbyHealthPanel

CAR-T Long Term Follow Up (LTFU) Study

ConditionLong Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age0-100
SponsorNovartis Pharmaceuticals

About this trial

Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 .

Disqualifiers

There are no specific exclusion criteria for this study.

Trial design

Design model

Single group

Treatments tested in this trial

  • Previously treated CAR-T patients

    Genetic

    Lentiviral-based CAR-T cell therapy

Treatment groups

1,105 Participants
are divided into 1 treatment group
Group A: Previously treated CAR-T patientsOther 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of patients with certain events (see description)

The percentage of pts with listed categories: New secondary malignancies, new serious infection, new incidence of serious neurologic disorder, New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, New incidence of a hematologic disorder

Time frame
at M3 post treatment, M6, M9, M12 and then, every 6M up to year 5, yearly until year 15.

Secondary outcomes

1

Percentage of patients with detectable CAR transgene levels in peripheral blood by q-PCR at pre- specified time points

Time frame
at M3 post treatment, M6, M9, M12 and every 6M up to year 5, yearly until year 15.
2

Percentage of patients with detectable RCL by VSV-G

Time frame
at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15
3

Percentage of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry;Incidence of death

Time frame
at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15.
4

B- and T- lymphocyte count

Time frame
at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novartis Pharmaceuticals

Lead sponsor

University of Pennsylvania

Collaborator

Source ClinicalTrials.gov
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