Recruiting

Jelmyto

Sponsor:

UroGen Pharma Ltd.

Code:

NCT05874921

Conditions

Urothelial Carcinoma

Urothelial Carcinoma Recurrent

Urothelial Carcinoma Ureter

Urothelial Carcinoma Ureter Recurrent

Urothelial Cancer of Renal Pelvis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Jelmyto (mitomycin) for pyelocalyceal solution

Study Details

Brief summary:

The purpose of this registry is to evaluate real world experience and outcomes of patients with Upper Tract Urothelial Cancer (UTUC) treated with Jelmyto in the United States.

Conditions

Urothelial Carcinoma

Urothelial Carcinoma Recurrent

Urothelial Carcinoma Ureter

Urothelial Carcinoma Ureter Recurrent

Urothelial Cancer of Renal Pelvis

Study ID

NCT05874921

Start date

Nov 17, 2023

Status verified date

Feb, 2025

Completion date

Jan, 2028

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults >18 years old and capable of giving informed consent.
  • Diagnosis of UTUC.
  • Receipt of at least 1 dose of JELMYTO after FDA approval (15 Apr 2020).

Exclusion Criteria:

  • Incapable of giving informed consent (e.g., incarcerated individuals, individuals with dementia).
  • Receipt of 1 or more doses of JELMYTO (also referred to as UGN-101 or Mitogel in clinical development) before FDA approval (on or before 15 Apr 2020).
  • Pregnancy or lactation.
  • Unable to comply with protocol requirements (for prospective data capture).
  • Any medical or mental condition(s) that makes participation in the Registry inadvisable in the opinion of the Investigator (for prospective data capture).

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Jelmyto

Patients with UTUC treated with Jelmyto

Interventions

Jelmyto (mitomycin) for pyelocalyceal solution

The dose of Jelmyto to be instilled is 4 mg per mL via ureteral catheter or a nephrostomy tube, with total instillation volume based on volumetric measurements using pyelography, not to exceed 15 mL (60 mg of mitomycin).

Instill Jelmyto once weekly for six weeks. For patients with a complete response 3 months after Jelmyto initiation, Jelmyto instillations may be administered once a month for a maximum of 11 additional instillations.

Primary outcome measure

  • Rate of CR or no evidence of disease (NED) at first evaluation post-treatment [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Michael Louie, MD, MPH, MSc

855-987-6436registry@urogen.com

Locations

Providence St. Johns Health Center

Recruiting

Santa Monica, California, United States, 90404

Contacts

Jennifer Linehan, MD

Jennifer.linehan@providence.org

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Padraic OMalley, MD

352-265-8240Padraic.O'Malley@urology.ufl.edu

Mount Sinai Medical Center of Florida, Inc.

Recruiting

Miami, Florida, United States, 33140

Contacts

Alan Nieder, MD

Alan.Nieder@msmc.com

H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.

Recruiting

Tampa, Florida, United States, 33612

Contacts

Wade Sexton, MD

Wade.Sexton@moffitt.org

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Joshua Meeks, MD

joshua.meeks@northwestern.edu

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Hristos Kaimakliotis, MD

hkaimakl@iupui.edu

The State University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Michael ODonnell, MD

michael-odonnell@uiowa.edu

Chesapeake Urology

Recruiting

Baltimore, Maryland, United States, 21204

Contacts

Rian Dickstein, MD

rdickstein@chesuro.com

Johns Hopkins Medical Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Nirmish Singla, MD

410-955-6100

Mass General Hospital (MGH)

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Adam Feldman, MD

afeldman@mgb.org

The Brigham and Womens Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Steven Chang, MD

SLCHANG@BWH.HARVARD.EDU

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Khurshid Ghani, MD

kghani@med.umich.edu

University of Missouri

Recruiting

Columbia, Missouri, United States, 65211

Contacts

Eliza DeFroda, MD

elddmc@health.missouri.edu

Rutgers

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Saum Ghodoussipour, MD

sg1621@cinj.rutgers.edu

The Feinstein Institutes for Medical Research

Recruiting

Lake Success, New York, United States, 11042

Contacts

David Hoenig, MD

dhoenig@northwell.edu

NYU Grossman School of Medicine

Recruiting

New York, New York, United States, 10016

Contacts

Katie Murray, MD

Katie.Murray@nyulangone.org

SUNY Upstate

Recruiting

Syracuse, New York, United States, 13210

Contacts

Joseph Jacob, MD

JacobJ@upstate.edu

The University of North Carolina Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Marc Bjurlin, MD

marc_bjurlin@med.unc.edu

Ohio State University

Recruiting

Columbus, Ohio, United States, 43202

Contacts

Ahmad Shabsigh, MD

614-685-4263Ahmad.Shabsigh@osumc.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Karthik Tanneru, MD

tanneru@musc.edu

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Brett Johnson, MD

Brett.Johnson@UTSouthwestern.edu

The University of Texas M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Mehrad Adibi, MD

MAdibi@mdanderson.org

More Information

Sponsor

UroGen Pharma Ltd.

Last update posted

Feb 28, 2025

Last verified

Feb, 2025

Keywords

  • Upper Tract Urothelial Cancer
  • UTUC
  • UGN-101
  • Mitomycin C
  • TCC
  • Ureteral
  • Upper Tract
  • Carcinoma
  • Kidney
  • Renal
  • Gel
  • Local
  • Prolonged Release
  • Slow Release
  • Kidney Sparing
  • Recurrence
  • Neoplasms by Histologic Type
  • Neoplasms
  • Urologic Neoplasms
  • Urogenital Neoplasms
  • Neoplasms by Site
  • Antibiotics, Antineoplastic
  • Antineoplastic Agents
  • Alkylating Agents
  • Nucleic Acid Synthesis Inhibitors
  • Enzyme Inhibitors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UroGen Pharma Ltd. on 2025-02-28.