CAR-T Long Term Follow Up (LTFU) Study (PAVO)

October 26, 2025 updated by: Novartis Pharmaceuticals

Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

1400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Novartis Pharmaceuticals
  • Phone Number: 1-888-669-6682

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Australia
      • Herston, Australia, QLD 4006
        • Recruiting
        • Novartis Investigative Site
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Novartis Investigative Site
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Novartis Investigative Site
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Novartis Investigative Site
      • Parkville, Victoria, Australia, 3052
        • Withdrawn
        • Novartis Investigative Site
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Novartis Investigative Site
  • Austria
      • Linz, Austria, 4020
        • Withdrawn
        • Novartis Investigative Site
      • Salzburg, Austria, 5020
        • Recruiting
        • Novartis Investigative Site
      • Vienna, Austria, 1090
        • Recruiting
        • Novartis Investigative Site
      • Vienna, Austria, A 1090
        • Recruiting
        • Novartis Investigative Site
  • Belgium
      • Ghent, Belgium, 9000
        • Recruiting
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Recruiting
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Recruiting
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Novartis Investigative Site
  • China
      • Beijing, China, 100036
        • Recruiting
        • Novartis Investigative Site
  • Denmark
      • Copenhagen, Denmark, DK-2100
        • Recruiting
        • Novartis Investigative Site
  • Finland
      • Helsinki, Finland, 00029
        • Recruiting
        • Novartis Investigative Site
  • France
      • Nantes, France, 44093
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75019
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75475
        • Recruiting
        • Novartis Investigative Site
      • Pierre-Bénite, France, 69495
        • Recruiting
        • Novartis Investigative Site
      • Villejuif, France, 94800
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Recruiting
        • Novartis Investigative Site
      • Ulm, Germany, 89081
        • Recruiting
        • Novartis Investigative Site
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Recruiting
        • Novartis Investigative Site
      • Regensburg, Bavaria, Germany, 93053
        • Recruiting
        • Novartis Investigative Site
      • Würzburg, Bavaria, Germany, 97080
        • Recruiting
        • Novartis Investigative Site
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Recruiting
        • Novartis Investigative Site
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Recruiting
        • Novartis Investigative Site
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • Novartis Investigative Site
  • Greece
      • Chaïdári, Greece, 124 62
        • Recruiting
        • Novartis Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Novartis Investigative Site
  • Israel
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Novartis Investigative Site
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Novartis Investigative Site
  • Italy
    • BO
      • Bologna, BO, Italy, 40138
        • Recruiting
        • Novartis Investigative Site
    • MB
      • Monza, MB, Italy, 20900
        • Recruiting
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italy, 20133
        • Recruiting
        • Novartis Investigative Site
      • Milan, MI, Italy, 20132
        • Recruiting
        • Novartis Investigative Site
      • Rozzano, MI, Italy, 20089
        • Recruiting
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00165
        • Recruiting
        • Novartis Investigative Site
      • Roma, RM, Italy, 00168
        • Recruiting
        • Novartis Investigative Site
  • Japan
      • Kyoto, Japan, 606 8507
        • Recruiting
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Recruiting
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060 8648
        • Recruiting
        • Novartis Investigative Site
    • Miyagi
      • Sendai, Miyagi, Japan, 980 8574
        • Recruiting
        • Novartis Investigative Site
    • Tokyo
      • Chuo Ku, Tokyo, Japan, 104 0045
        • Withdrawn
        • Novartis Investigative Site
  • Netherlands
      • Utrecht, Netherlands, 3584 CS
        • Completed
        • Novartis Investigative Site
      • Utrecht, Netherlands, 3584 CX
        • Withdrawn
        • Novartis Investigative Site
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Completed
        • Novartis Investigative Site
  • Norway
      • Oslo, Norway, 0424
        • Recruiting
        • Novartis Investigative Site
      • Oslo, Norway, 0310
        • Recruiting
        • Novartis Investigative Site
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • Recruiting
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169608
        • Recruiting
        • Novartis Investigative Site
      • Singapore, Singapore, 119074
        • Recruiting
        • Novartis Investigative Site
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 05505
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 03722
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 06351
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28046
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28009
        • Recruiting
        • Novartis Investigative Site
      • Seville, Spain, 41013
        • Recruiting
        • Novartis Investigative Site
      • Valencia, Spain, 46010
        • Recruiting
        • Novartis Investigative Site
    • Barcelona
      • Esplugues, Barcelona, Spain, 08950
        • Recruiting
        • Novartis Investigative Site
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Novartis Investigative Site
    • Castille and León
      • Salamanca, Castille and León, Spain, 37007
        • Recruiting
        • Novartis Investigative Site
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Recruiting
        • Novartis Investigative Site
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Novartis Investigative Site
  • Taiwan
      • Taipei, Taiwan, 10002
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Completed
        • Mayo Clinic Arizona
    • California
      • Duarte, California, United States, 91010 3000
        • Recruiting
        • City of Hope National Medical Center
        • Principal Investigator:
          • Leslie Popplewell
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Medical Center
        • Principal Investigator:
          • Aravind Ramakrishnan
        • Contact:
          • Phone Number: 310-825-4493
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Childrens Hospital Los Angeles
        • Principal Investigator:
          • Alan Wayne
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF Medical Center
        • Principal Investigator:
          • Charalambos Andreadis
        • Contact:
      • Stanford, California, United States, 94304
        • Recruiting
        • Stanford University Medical Center
        • Principal Investigator:
          • Kara Davis
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Childrens Healthcare of Atlanta
        • Principal Investigator:
          • Muna Qayed
        • Contact:
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University School of Medicine/Winship Cancer Institute
        • Contact:
        • Principal Investigator:
          • Jonathon Cohen
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University School of Medicine-Winship Cancer Institute
        • Principal Investigator:
          • Jonathon Cohen
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center, Hematology & Oncology
        • Contact:
        • Principal Investigator:
          • Michael R. Bishop
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • Uni of Chi Medi Ctr Hema and Onco
        • Contact:
        • Principal Investigator:
          • Michael R Bishop
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Cancer Center
        • Principal Investigator:
          • Joseph P McGuirk
        • Contact:
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Cancer Center SC
        • Contact:
        • Principal Investigator:
          • Joseph P McGuirk
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Matthew Frigault
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
        • Principal Investigator:
          • Adam Sperling
        • Contact:
          • Phone Number: 617-632-3985
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Med Center
        • Contact:
          • Phone Number: 617-667-7000
        • Principal Investigator:
          • Jacalyn Rosenblatt
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-2800
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Gregory Yanik
        • Contact:
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Health System SC CTL019
        • Contact:
        • Principal Investigator:
          • John Magenau
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • Uni Of Michigan Health System
        • Principal Investigator:
          • John Magenau
        • Contact:
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University-Karmanos Cancer Institute
        • Principal Investigator:
          • Abhinav Deol
        • Contact:
          • Phone Number: 313-576-8716
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Withdrawn
        • University of Minnesota
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children s Mercy Hospital
        • Principal Investigator:
          • Gary D. Myers
        • Contact:
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospital SC
        • Principal Investigator:
          • Gary D. Myers
        • Contact:
        • Principal Investigator:
          • Gary Myers, MD
    • New York
      • New York, New York, United States, 10065
        • Withdrawn
        • Weill Cornell Medical College
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke Unversity Medical Center SC - CTL019B2205J
        • Contact:
        • Principal Investigator:
          • Paul L. Martin
        • Contact:
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke Unversity Medical Center
        • Principal Investigator:
          • Paul L. Martin
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Stella M. Davies
      • Cincinnati, Ohio, United States, 45229-3039
        • Recruiting
        • Cinn Children Hosp Medical Center
        • Principal Investigator:
          • Stella M. Davies
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio ST Compr Cancer Ctr James Hosp
        • Principal Investigator:
          • David A Bond
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
        • Principal Investigator:
          • Brandon Hayes-Lattin
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health Sciences University
        • Principal Investigator:
          • Brandon Hayes-Lattin
        • Contact:
          • Mai-Lee Lee Yap
          • Phone Number: +1 503 494 6865
          • Email: yap@ohsu.edu
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Principal Investigator:
          • Noelle Frey
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Principal Investigator:
          • Usama Gergis
        • Contact:
          • Phone Number: 215-955-8699
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • The Childrens Hosp of Philadelphia
        • Principal Investigator:
          • Stephan Grupp
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute
        • Principal Investigator:
          • Ian W Flinn
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Principal Investigator:
          • Samuel John
        • Contact:
      • Dallas, Texas, United States, 75235
        • Recruiting
        • UTSW/Children's Medical Center
        • Principal Investigator:
          • Theodore Laetsch
        • Contact:
        • Principal Investigator:
          • Theodore Laetsch, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Principal Investigator:
          • Jason Westin
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center SC
        • Principal Investigator:
          • Jason Westin
        • Contact:
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah Clinical Trials Office
        • Principal Investigator:
          • Michael Pulsipher
        • Contact:
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University Of Wisconsin Hospital
        • Principal Investigator:
          • Christian Capitini
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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 Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients 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.
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 Measures

Outcome Measure
Time Frame
Percentage 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.
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
Time Frame: at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15
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
Time Frame: at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15.
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.
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.
at M3 post treatment then M6, M12 and every year until year 15.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Collaborators

University of Pennsylvania

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2015

Primary Completion (Estimated)

February 22, 2036

Study Completion (Estimated)

February 22, 2036

Study Registration Dates

First Submitted

May 1, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (Estimated)

May 15, 2015

Study Record Updates

Last Update Posted (Estimated)

October 28, 2025

Last Update Submitted That Met QC Criteria

October 26, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CCTL019A2205B
  • 2014-001673-14 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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