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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

OTHER

Phase

PHASE3

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

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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

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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

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/Arm	Intervention/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 Measure	Primary Outcome Description	Primary 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 disorder	at M3 post treatment, M6, M9, M12 and then, every 6M up to year 5, yearly until year 15.

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Percentage of patients with detectable CAR transgene levels in peripheral blood by q-PCR at pre- specified time points	Not Specified	at 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-G	Not Specified	at 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 death	Not Specified	at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15.
B- and T- lymphocyte count	Not Specified	at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15.
Height and weight, Tanner staging, menstruation status	Not Specified	at M3 post treatment then M6, M12 and every year until year 15.

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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