CAR-T Long Term Follow Up (LTFU) Study
Novartis Pharmaceuticals · with University of Pennsylvania · NCT02445222
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 0 mo–100 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 1105
- US sites recruiting
- 41
- Study start
- November 2, 2015
- Record last updated
- October 2, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Previously treated CAR-T patients
Conditions: Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
City of Hope National Medical Center
Duarte, CA 91010-3000
Site contact: Leslie Popplewell
Childrens Hospital Los Angeles
Los Angeles, CA 90027
Site contact: Renna Killen · 323-361-5812 · rkillen@chla.usc.edu
UCLA Medical Center
Los Angeles, CA 90095
Site contact: 310-825-4493
UCSF Medical Center
San Francisco, CA 94143
Site contact: Kerri Yen · 415-514-6281 · Kerri.yen@ucsf.edu
Stanford University Medical Center
Stanford, CA 94304
Site contact: Christina Baggott · 650-723-4000 · Baggott@stanford.edu
Emory University School of Medicine-Winship Cancer Institute
Atlanta, GA 30322
Site contact: Kenyatta Scott · kbscot3@emory.edu
Emory University School of Medicine/Winship Cancer Institute
Atlanta, GA 30322
Site contact: Keshawna L. Sherer · 404-778-3708 · keshawna.sherer@emoryhealthcare.org
Childrens Healthcare of Atlanta
Atlanta, GA 30342
Site contact: Kelsey Rogowski · 404-785-2125 · kelsey.rogowski@choa.org
Uni of Chi Medi Ctr Hema and Onco
Chicago, IL 60637
Site contact: Thomas Althaus · 773-834-0982 · talthaus@bsd.uchicago.edu
University of Chicago Medical Center, Hematology & Oncology
Chicago, IL 60637
Site contact: Howie Weiner · 773-834-0982 · hweiner@medicine.bsd.uchicago.edu
University of Kansas Cancer Center SC
Westwood, KS 66205
Site contact: Janie Smart · 913-588-6029 · nsmart@kumc.edu
University of Kansas Cancer Center
Westwood, KS 66205
Site contact: Christina Hardin · 913-588-6029 · chardin@kumc.edu
Massachusetts General Hospital
Boston, MA 02114
Site contact: Matthew Frigault
Beth Israel Deaconess Med Center
Boston, MA 02215
Site contact: 617-667-7000
Dana Farber Cancer Institute
Boston, MA 02215
Site contact: 617-632-3985
University of Michigan
Ann Arbor, MI 48109-2800
Site contact: Connie Varner · convarne@med.umich.edu
Uni Of Michigan Health System
Ann Arbor, MI 48109
Site contact: Sheryl Morgan · 734-936-8538 · shermorg@med.umich.edu
University of Michigan Health System SC CTL019
Ann Arbor, MI 48109
Site contact: Michelle Smith Tucker · 734-936-8538 · smimiche@umich.edu
Wayne State University-Karmanos Cancer Institute
Detroit, MI 48201
Site contact: 313-576-8716
Children s Mercy Hospital
Kansas City, MO 64108
Site contact: Rachel Wilcox · 816-855-1886 · rwilcox@cmh.edu
Children's Mercy Hospital SC
Kansas City, MO 64108
Site contact: Rachel Wilcox · 816-302-6851 · rwilcox@cmh.edu
Duke Unversity Medical Center SC - CTL019B2205J
Durham, NC 27705
Site contact: Kristine Edwards · 919-668-2967 · kristine.gurganus@dm.duke.edu
Duke Unversity Medical Center
Durham, NC 27705
Site contact: Erin Arbuckle · Erin.arbuckle@duke.edu
Cincinnati Children's Hospital Medical Center
Cincinnati, OH 45229-3039
Site contact: Melanie Jordan · 513-636-9292 · melanie.jordan@cchmc.org
Cinn Children Hosp Medical Center
Cincinnati, OH 45229-3039
Site contact: Stephanie Edwards · 513-636-9292 · stephaniel.edwards@cchmc.org
Ohio ST Compr Cancer Ctr James Hosp
Columbus, OH 43210
Site contact: Allyson Miller · 614-688-9494 · allyson.miller@osumc.edu
Oregon Health & Science University
Portland, OR 97239
Site contact: Beth Zentzis · 503-346-1507 · zentzis@ohsu.edu
Oregon Health Sciences University
Portland, OR 97239
Site contact: Rebecca Hulme · 503-494-6865 · hulmer@ohsu.edu
The Childrens Hosp of Philadelphia
Philadelphia, PA 19104
Site contact: Elizabeth McBride · 215-590-7399 · mcbridee@email.chop.edu
University of Pennsylvania
Philadelphia, PA 19104
Site contact: Michelle Caylor · 215-898-9256 · mcaylor@mail.med.upenn.edu
University of Pennsylvania
Philadelphia, PA 19104
Site contact: Jacqui Rick · 215-615-1725 · Jacqui.Rick@pennmedicine.upenn.edu
Thomas Jefferson University
Philadelphia, PA 19107
Site contact: 215-955-8699
Tennessee Oncology
Nashville, TN 37203
Site contact: Ian W Flinn
UTSW/Children's Medical Center
Dallas, TX 75235
Site contact: Alison Patterson · 214-456-2726 · Alison.patterson@childrens.com
University of Texas Southwestern Medical Center
Dallas, TX 75390
Site contact: Jillian MacManus · 214-648-6449 · jillian.macmanus@childrens.com
MD Anderson Cancer Center SC
Houston, TX 77030
Site contact: Souzanne T. Ouzounian · 713-792-2171 · souzouni@mdanderson.org
MD Anderson Cancer Center
Houston, TX 77030
Site contact: Manasi Chauhan · 713-792-2171 · MYChauhan@mdanderson.org
University of Utah Clinical Trials Office
Salt Lake City, UT 84108
Site contact: Luke Stone · 801-213-3395 · luke.stone@hsc.utah.edu
University of Utah Clinical Trials Office
Salt Lake City, UT 84108
Site contact: Luke Stone · 801-213-3401 · luke.stone@hsc.utah.edu
University of Wisconsin Hospital and Clinics
Madison, WI 53792
Site contact: Jenny Weiland · 608-890-8070 · PedsHemOncResearch@lists.wisc.edu
University of Wisconsin Hospital
Madison, WI 53792
Site contact: Jenny Weiland · jlkimball@pediatrics.wisc.edu
Study contacts (from the official record)
- Novartis Pharmaceuticals · 1-888-669-6682
- Novartis Pharmaceuticals · +41613241111