CAR-T Long Term Follow Up (LTFU) Study

  • STATUS
    Recruiting
  • End date
    Feb 22, 2036
  • participants needed
    1250
  • sponsor
    Novartis Pharmaceuticals
Updated on 9 June 2021
Novartis Investigative Site (1.4 mi away) Contact
+23 other location

Summary

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.

Description

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.

Details
Condition Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy, Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy, Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy, Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy, Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy, Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy, Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy, Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy, Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy, Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy, Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy, Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy, Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy, Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy, Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
Treatment Previously treated CART CD 19 patients, Previously treated CAR-T patients
Clinical Study IdentifierNCT02445222
SponsorNovartis Pharmaceuticals
Last Modified on9 June 2021

Eligibility

Yes No Not Sure

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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