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Trial record 1 of 1 for:    NCT02445222
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CAR-T Long Term Follow Up (LTFU) Study (PAVO)

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ClinicalTrials.gov Identifier: NCT02445222
Recruitment Status : Recruiting
First Posted : May 15, 2015
Last Update Posted : July 10, 2020
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE May 1, 2015
First Posted Date  ICMJE May 15, 2015
Last Update Posted Date July 10, 2020
Actual Study Start Date  ICMJE November 2, 2015
Estimated Primary Completion Date April 27, 2035   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 12, 2015)
Proportion of pts with listed categories:New malignancies, incidence/exacerbation of pre-existing neurologic disorder,New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder,New incidence of a hematologic disorder [ Time Frame: 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
  • 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. ]
  • 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 ]
  • 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. ]
  • 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. ]
  • Height and weight, Tanner staging, menstruation status [ Time Frame: at M3 post treatment then M6, M12 and every year until year 15. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2015)
  • Proportion of patients with detectable CD19 CAR transgene levels in peripheral blood by q-PCR at pre- specified post CD19 CART infusion time points [ Time Frame: 2 monthly until year 1, 3 monthly until year 5, yearly until year 15. ]
  • Proportion of patients with detectable RCL by VSV-G [ Time Frame: 2 monthly until year 1, 3 monthly until year 5, yearly until year 5. ]
  • 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: 2 monthly until year 1, 3 monthly until year 5, yearly until year 15. ]
  • Absolute B- and T- lymphocyte count [ Time Frame: 2 monthly until year 1, 3 monthly until year 5, yearly until year 15. ]
  • Height and weight, Tanner staging, menstrual cycle status [ Time Frame: 2 monthly until year 1, 3 monthly until year 5, yearly until year 15. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CAR-T Long Term Follow Up (LTFU) Study
Official Title  ICMJE Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
Intervention  ICMJE Genetic: Previously treated CAR-T patients
Lentiviral-based CAR-T cell therapy
Study Arms  ICMJE Previously treated CAR-T patients
Patients who previously were exposed to lentiviral-based CART cell therapy
Intervention: Genetic: Previously treated CAR-T patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 30, 2019)
1250
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2015)
500
Estimated Study Completion Date  ICMJE April 28, 2035
Estimated Primary Completion Date April 27, 2035   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Italy,   Japan,   Netherlands,   Norway,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02445222
Other Study ID Numbers  ICMJE CCTL019A2205B
2014-001673-14 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE University of Pennsylvania
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP