AzTrials
AzTrials

Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access ProgramPhase 3PAVONCT02445222

CAR-T Long Term Follow Up (LTFU) Study

A Phase 3 study testing Previously treated CAR-T patients in people with Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, run by Novartis Pharmaceuticals at 120 sites in 23 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 0 to 100 years
What is being tested?
Previously treated CAR-T patients
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,105 participants
Where
120 sitesin 23 countries
Study dates
2 Nov 2015to 18 Apr 2039
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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 .

Who cannot join

  • There are no specific exclusion criteria for this study.

Trial locations and contacts

120 sites in 23 countries. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

1-888-669-6682

Novartis Pharmaceuticals contact

+41613241111

120 sites in 23 countries

United States44 sites, 41 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109-2800

    Connie Varner, convarne@med.umich.edu

    Gregory Yanik

    Recruiting

  • Uni Of Michigan Health System

    Ann Arbor, Michigan, 48109

    Sheryl Morgan, 734-936-8538, shermorg@med.umich.edu

    John Magenau

    Recruiting

  • University of Michigan Health System SC CTL019

    Ann Arbor, Michigan, 48109

    Michelle Smith Tucker, 734-936-8538, smimiche@umich.edu

    John Magenau

    Recruiting

  • Emory University School of Medicine-Winship Cancer Institute

    Atlanta, Georgia, 30322

    Kenyatta Scott, kbscot3@emory.edu

    Jonathon Cohen

    Recruiting

  • Emory University School of Medicine/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Keshawna L. Sherer, 404-778-3708, keshawna.sherer@emoryhealthcare.org

    Jonathon Cohen

    Recruiting

  • Childrens Healthcare of Atlanta

    Atlanta, Georgia, 30342

    Kelsey Rogowski, 404-785-2125, kelsey.rogowski@choa.org

    Muna Qayed

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Matthew Frigault

    Recruiting

  • Beth Israel Deaconess Med Center

    Boston, Massachusetts, 02215

    617-667-7000

    Jacalyn Rosenblatt

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    617-632-3985

    Adam Sperling

    Recruiting

  • Uni of Chi Medi Ctr Hema and Onco

    Chicago, Illinois, 60637

    Thomas Althaus, 773-834-0982, talthaus@bsd.uchicago.edu

    Michael R Bishop

    Recruiting

  • University of Chicago Medical Center, Hematology & Oncology

    Chicago, Illinois, 60637

    Howie Weiner, 773-834-0982, hweiner@medicine.bsd.uchicago.edu

    Michael R. Bishop

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3039

    Melanie Jordan, 513-636-9292, melanie.jordan@cchmc.org

    Stella M. Davies

    Recruiting

  • Cinn Children Hosp Medical Center

    Cincinnati, Ohio, 45229-3039

    Stephanie Edwards, 513-636-9292, stephaniel.edwards@cchmc.org

    Stella M. Davies

    Recruiting

  • Ohio ST Compr Cancer Ctr James Hosp

    Columbus, Ohio, 43210

    Allyson Miller, 614-688-9494, allyson.miller@osumc.edu

    Samantha Jaglowski

    Recruiting

  • UTSW/Children's Medical Center

    Dallas, Texas, 75235

    Alison Patterson, 214-456-2726, Alison.patterson@childrens.com

    Theodore Laetsch, MD

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Jillian MacManus, 214-648-6449, jillian.macmanus@childrens.com

    Samuel John

    Recruiting

  • Wayne State University-Karmanos Cancer Institute

    Detroit, Michigan, 48201

    313-576-8716

    Abhinav Deol

    Recruiting

  • City of Hope National Medical Center

    Duarte, California, 91010-3000

    Leslie Popplewell

    Recruiting

  • Duke Unversity Medical Center SC - CTL019B2205J

    Durham, North Carolina, 27705

    Kristine Edwards, 919-668-2967, kristine.gurganus@dm.duke.edu

    Erin Arbuckle, 919-684-3293, erin.arbuckle@duke.edu

    Recruiting

  • Duke Unversity Medical Center

    Durham, North Carolina, 27705

    Erin Arbuckle, Erin.arbuckle@duke.edu

    Paul L. Martin

    Recruiting

  • MD Anderson Cancer Center SC

    Houston, Texas, 77030

    Souzanne T. Ouzounian, 713-792-2171, souzouni@mdanderson.org

    Laura Hargraves, 713-792-6594, lehargraves@mdanderson.org

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Manasi Chauhan, 713-792-2171, MYChauhan@mdanderson.org

    Jason R Westin

    Recruiting

  • Children s Mercy Hospital

    Kansas City, Missouri, 64108

    Rachel Wilcox, 816-855-1886, rwilcox@cmh.edu

    Gary D. Myers

    Recruiting

  • Children's Mercy Hospital SC

    Kansas City, Missouri, 64108

    Rachel Wilcox, 816-302-6851, rwilcox@cmh.edu

    Gary Myers, MD

    Recruiting

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027

    Renna Killen, 323-361-5812, rkillen@chla.usc.edu

    Alan Wayne

    Recruiting

  • UCLA Medical Center

    Los Angeles, California, 90095

    310-825-4493

    Aravind Ramakrishnan

    Recruiting

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

    Jenny Weiland, 608-890-8070, PedsHemOncResearch@lists.wisc.edu

    Celeste Matsushima, +1 608-890-8069, camatsus@pediatrics.wisc.edu

    Recruiting

  • University of Wisconsin Hospital

    Madison, Wisconsin, 53792

    Jenny Weiland, jlkimball@pediatrics.wisc.edu

    Christian Capitini

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Withdrawn

  • Tennessee Oncology

    Nashville, Tennessee, 37203

    Ian W Flinn

    Recruiting

  • Weill Cornell Medical College

    New York, New York, 10065

    Withdrawn

  • The Childrens Hosp of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Elizabeth McBride, 215-590-7399, mcbridee@email.chop.edu

    Stephan Grupp

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Michelle Caylor, 215-898-9256, mcaylor@mail.med.upenn.edu

    Noelle Frey

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Jacqui Rick, 215-615-1725, Jacqui.Rick@pennmedicine.upenn.edu

    Noelle Frey

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    215-955-8699

    Usama Gergis

    Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

    Completed

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Beth Zentzis, 503-346-1507, zentzis@ohsu.edu

    Brandon Hayes-Lattin

    Recruiting

  • Oregon Health Sciences University

    Portland, Oregon, 97239

    Rebecca Hulme, 503-494-6865, hulmer@ohsu.edu

    Brandon Hayes-Lattin

    Recruiting

  • University of Utah Clinical Trials Office

    Salt Lake City, Utah, 84108

    Luke Stone, 801-213-3395, luke.stone@hsc.utah.edu

    Michael Boyer, MD

    Recruiting

  • University of Utah Clinical Trials Office

    Salt Lake City, Utah, 84108

    Luke Stone, 801-213-3401, luke.stone@hsc.utah.edu

    Michael Pulsipher

    Recruiting

  • UCSF Medical Center

    San Francisco, California, 94143

    Kerri Yen, 415-514-6281, Kerri.yen@ucsf.edu

    Charalambos Andreadis

    Recruiting

  • Stanford University Medical Center

    Stanford, California, 94304

    Christina Baggott, 650-723-4000, Baggott@stanford.edu

    Kara Davis

    Recruiting

  • University of Kansas Cancer Center SC

    Westwood, Kansas, 66205

    Janie Smart, 913-588-6029, nsmart@kumc.edu

    Joseph P McGuirk

    Recruiting

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

    Christina Hardin, 913-588-6029, chardin@kumc.edu

    Joseph P McGuirk

    Recruiting

Other trials in United States

Spain11 sites, 11 recruiting

  • Novartis Investigative Site

    Barcelona, 08035

    Recruiting

  • Novartis Investigative Site

    Barcelona, 08041

    Recruiting

  • Novartis Investigative Site

    Esplugues, Barcelona, 08950

    Recruiting

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907

    Recruiting

  • Novartis Investigative Site

    Madrid, 28009

    Recruiting

  • Novartis Investigative Site

    Madrid, 28041

    Recruiting

  • Novartis Investigative Site

    Madrid, 28046

    Recruiting

  • Novartis Investigative Site

    Pamplona, Navarre, 31008

    Recruiting

  • Novartis Investigative Site

    Salamanca, 37007

    Recruiting

  • Novartis Investigative Site

    Seville, 41013

    Recruiting

  • Novartis Investigative Site

    Valencia, 46010

    Recruiting

Other trials in Spain

Germany9 sites, 9 recruiting

  • Novartis Investigative Site

    Berlin, 13353

    Recruiting

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937

    Recruiting

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590

    Recruiting

  • Novartis Investigative Site

    Hamburg, 20246

    Recruiting

  • Novartis Investigative Site

    Leipzig, Saxony, 04103

    Recruiting

  • Novartis Investigative Site

    Munich, Bavaria, 81377

    Recruiting

  • Novartis Investigative Site

    Regensburg, Bavaria, 93053

    Recruiting

  • Novartis Investigative Site

    Ulm, 89081

    Recruiting

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080

    Recruiting

Other trials in Germany

France8 sites, 8 recruiting

  • Novartis Investigative Site

    Nantes, 44093

    Recruiting

  • Novartis Investigative Site

    Paris, 75013

    Recruiting

  • Novartis Investigative Site

    Paris, 75019

    Recruiting

  • Novartis Investigative Site

    Paris, 75475

    Recruiting

  • Novartis Investigative Site

    Pessac, 33604

    Recruiting

  • Novartis Investigative Site

    Pierre-Bénite, 69495

    Recruiting

  • Novartis Investigative Site

    Strasbourg, 67091

    Recruiting

  • Novartis Investigative Site

    Villejuif, 94800

    Recruiting

Other trials in France

Italy7 sites, 7 recruiting

  • Novartis Investigative Site

    Bologna, BO, 40138

    Recruiting

  • Novartis Investigative Site

    Milan, MI, 20132

    Recruiting

  • Novartis Investigative Site

    Milan, MI, 20133

    Recruiting

  • Novartis Investigative Site

    Monza, MB, 20900

    Recruiting

  • Novartis Investigative Site

    Roma, RM, 00165

    Recruiting

  • Novartis Investigative Site

    Roma, RM, 00168

    Recruiting

  • Novartis Investigative Site

    Rozzano, MI, 20089

    Recruiting

Other trials in Italy

Australia6 sites, 5 recruiting

  • Novartis Investigative Site

    Camperdown, New South Wales, 2050

    Recruiting

  • Novartis Investigative Site

    Herston, 4006

    Recruiting

  • Novartis Investigative Site

    Melbourne, Victoria, 3000

    Recruiting

  • Novartis Investigative Site

    Melbourne, Victoria, 3004

    Recruiting

  • Novartis Investigative Site

    Murdoch, Western Australia, 6150

    Recruiting

  • Novartis Investigative Site

    Parkville, Victoria, 3052

    Withdrawn

Other trials in Australia

Japan5 sites, 4 recruiting

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 1040045

    Withdrawn

  • Novartis Investigative Site

    Fukuoka, 8128582

    Recruiting

  • Novartis Investigative Site

    Kyoto, 6068507

    Recruiting

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0608648

    Recruiting

  • Novartis Investigative Site

    Sendai, Miyagi, 9808574

    Recruiting

Other trials in Japan

Canada4 sites, 4 recruiting

  • Novartis Investigative Site

    Hamilton, Ontario, L8V 1C3

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, H1T 2M4

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1C5

    Recruiting

  • Novartis Investigative Site

    Toronto, Ontario, M5G 1X8

    Recruiting

Other trials in Canada

South Korea4 sites, 4 recruiting

  • Novartis Investigative Site

    Seoul, 03080

    Recruiting

  • Novartis Investigative Site

    Seoul, 03722

    Recruiting

  • Novartis Investigative Site

    Seoul, 05505

    Recruiting

  • Novartis Investigative Site

    Seoul, 06351

    Recruiting

Other trials in South Korea

Austria3 sites, 2 recruiting

  • Novartis Investigative Site

    Linz, 4020

    Withdrawn

  • Novartis Investigative Site

    Salzburg, 5020

    Recruiting

  • Novartis Investigative Site

    Vienna, 1090

    Recruiting

Other trials in Austria

Netherlands3 sites

  • Novartis Investigative Site

    Amsterdam, North Holland, 1105 AZ

    Completed

  • Novartis Investigative Site

    Utrecht, 3584 CS

    Completed

  • Novartis Investigative Site

    Utrecht, 3584 CX

    Withdrawn

Other trials in Netherlands

Israel2 sites, 2 recruiting

  • Novartis Investigative Site

    Ramat Gan, 5265601

    Recruiting

  • Novartis Investigative Site

    Tel Aviv, 6423906

    Recruiting

Other trials in Israel

Norway2 sites, 2 recruiting

  • Novartis Investigative Site

    Oslo, 0310

    Recruiting

  • Novartis Investigative Site

    Oslo, 0424

    Recruiting

Other trials in Norway

Singapore2 sites, 2 recruiting

  • Novartis Investigative Site

    Singapore, 119074

    Recruiting

  • Novartis Investigative Site

    Singapore, 169608

    Recruiting

Other trials in Singapore

United Kingdom2 sites, 2 recruiting

  • Novartis Investigative Site

    Birmingham, West Midlands, B15 2TH

    Recruiting

  • Novartis Investigative Site

    London, SE5 9RS

    Recruiting

Other trials in United Kingdom

Belgium1 site, 1 recruiting

  • Novartis Investigative Site

    Ghent, 9000

    Recruiting

Other trials in Belgium

China1 site, 1 recruiting

  • Novartis Investigative Site

    Beijing, 100036

    Recruiting

Other trials in China

Denmark1 site, 1 recruiting

  • Novartis Investigative Site

    Copenhagen, 2100

    Recruiting

Other trials in Denmark

Finland1 site, 1 recruiting

  • Novartis Investigative Site

    Helsinki, 00029

    Recruiting

Other trials in Finland

Greece1 site, 1 recruiting

  • Novartis Investigative Site

    Chaïdári, 124 62

    Recruiting

Other trials in Greece

Hong Kong1 site, 1 recruiting

  • Novartis Investigative Site

    Hong Kong, 999077

    Recruiting

Other trials in Hong Kong

Saudi Arabia1 site, 1 recruiting

  • Novartis Investigative Site

    Riyadh, 11211

    Recruiting

Other trials in Saudi Arabia

Taiwan1 site, 1 recruiting

  • Novartis Investigative Site

    Taipei, 10002

    Recruiting

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
Previously treated CAR-T patients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Previously treated CAR-T patientsGenetic

    Lentiviral-based CAR-T cell therapy

Study groups in NCT02445222
Study groupRoleWhat they receive
Previously treated CAR-T patientsOtherPatients who previously were exposed to lentiviral-based CART cell therapy
Receives: Genetic: Previously treated CAR-T patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: at M3 post treatment, M6, M9, M12 and then, every 6M up to year 5, yearly until year 15.

Secondary outcomes (5)

  1. Percentage of patients with detectable CAR transgene levels in peripheral blood by q-PCR at pre- specified time points

    Measured: at M3 post treatment, M6, M9, M12 and every 6M up to year 5, yearly until year 15.

  2. Percentage of patients with detectable RCL by VSV-G

    Measured: at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15

  3. Percentage of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry;Incidence of death

    Measured: 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

    Measured: 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

    Measured: at M3 post treatment then M6, M12 and every year until year 15.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2015 (estimated)
  2. Study start2 Nov 2015
  3. Primary completion18 Apr 2039 (estimated)
  4. Study completion18 Apr 2039 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02445222
Sponsor's protocol ID
CCTL019A2205B
Other IDs
2014-001673-14, 2014
Acronym
PAVO
Status last verified
Sep 2026
First submitted
1 May 2015
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Maziarz RT, Bishop MR, Tam CS, Borchmann P, Worel N, McGuirk JP, Holte H, Waller EK, Jaglowski S, Andreadis C, Foley SR, Westin JR, Fleury I, Ho PJ, Mielke S, Teshima T, Janakiram M, Hsu J, Izutsu K, Kersten MJ, Ghosh M, Wagner-Johnston N, Kato K, Corradini P, Ma W, Han X, Nuortti M, Awasthi R, Mundt KE, Majdan M, Maier HJ, Jegerlehner A, Salles G, Schuster SJ. Five-Year Analysis of the JULIET Trial of Tisagenlecleucel in Patients With Relapsed/Refractory Large B-Cell Lymphoma. J Clin Oncol. 2026 Jan 10;44(2):86-91. doi: 10.1200/JCO-25-00507. Epub 2025 Nov 18.

    PubMed 41252666

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Previously treated CAR-T patients in people with Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, run by Novartis Pharmaceuticals at 120 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Spain, Germany, France, Italy and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (1-888-669-6682), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02445222, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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