CAR-T Long Term Follow Up (LTFU) Study

PHASE3RECRUITING

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.

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Study details:

Patients are enrolled following completion or early discontinuation from a Novartis sponsored or supported study of CAR T-Cell treatment. Patients will be followed for 15 years post treatment from the last treatment. They will be monitored for safety and efficacy within the primary treatment protocols for the protocol defined duration.

Patients can drop off treatment protocols at any time to enter this long term Follow up study. Patients discontinuing from the primary treatment protocols for any reason will be enrolled in this long term follow up (LTFU). This will allow collecting data on long term safety and efficacy (as applicable) as mandated by the health authorities of all patients treated with CAR-T therapy within the concept of a single protocol.

Collection of such long term effects of CAR-T cell therapy will help to further define the risk-benefit profile of CAR-T Therapies.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.
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    Eligibility

    Age eligible for study : 0 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2016-01-05

    Primary completion: 2036-02-22

    Study completion finish: 2036-02-22

    study type

    Study type

    OTHER

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT02445222

    Intervention or treatment

    GENETIC: Previously treated CAR-T patients

    Conditions

    • Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
    Image related to Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
    • Condition: Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program

    • GENETIC: Previously treated CAR-T patients

    • Melbourne, Victoria, Australia and more

    • Sponsor: Novartis Pharmaceuticals

    Find a site

    Closest Location:

    Novartis Investigative Site

    Research sites nearby

    Select from list below to view details:

    • Novartis Investigative Site

      Melbourne, Victoria, Australia

    • Novartis Investigative Site

      Parkville, Victoria, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    OTHER: Previously treated CAR-T patients
    • Patients who previously were exposed to lentiviral-based CART cell therapy
    GENETIC: Previously treated CAR-T patients
    • Lentiviral-based CAR-T cell therapy

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    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 disorderat M3 post treatment, M6, M9, M12 and then, every 6M up to year 5, yearly until year 15.

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Percentage of patients with detectable CAR transgene levels in peripheral blood by q-PCR at pre- specified time pointsNot Specifiedat M3 post treatment, M6, M9, M12 and every 6M up to year 5, yearly until year 15.
    Percentage of patients with detectable RCL by VSV-GNot Specifiedat M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15
    Percentage of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry;Incidence of deathNot Specifiedat M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15.
    B- and T- lymphocyte countNot Specifiedat M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15.
    Height and weight, Tanner staging, menstruation statusNot Specifiedat M3 post treatment then M6, M12 and every year until year 15.

    Frequently Asked Questions

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    References

    Clinical Trials Gov: CAR-T Long Term Follow Up (LTFU) Study

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