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Trial record 1 of 1 for:    CCTL019A2205B
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CAR-T Long Term Follow Up (LTFU) Study (PAVO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02445222
Recruitment Status : Recruiting
First Posted : May 15, 2015
Last Update Posted : September 21, 2020
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program Genetic: Previously treated CAR-T patients Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy
Actual Study Start Date : November 2, 2015
Estimated Primary Completion Date : April 27, 2035
Estimated Study Completion Date : April 28, 2035

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Proportion of pts with certain events (see description) [ Time Frame: at M3 post treatment, M6, M9, M12 and then, every 6M up to year 5, yearly until year 15. ]
    Proportion 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


Secondary Outcome Measures :
  1. Proportion 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. Proportion 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. Proportion 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. ]
  5. Height and weight, Tanner staging, menstruation status [ Time Frame: at M3 post treatment then M6, M12 and every year until year 15. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445222


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111

Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
University of Pennsylvania
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02445222    
Other Study ID Numbers: CCTL019A2205B
2014-001673-14 ( EudraCT Number )
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No