uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto

NCT05874921 · tracked via the Priya Life Science USA tracker

Sponsor

UroGen Pharma Ltd.

Phase

Observational

Started

2023-11-17

Last updated

2025-02-28

Condition(s) studied

Urothelial CarcinomaUrothelial Carcinoma RecurrentUrothelial Carcinoma UreterUrothelial Carcinoma Ureter RecurrentUrothelial Cancer of Renal PelvisUrothelial Carcinoma of the Renal Pelvis and UreterCarcinoma, Transitional CellTransitional Cell Carcinoma of Renal Pelvis

Investigational drug(s) / intervention(s)

Jelmyto (mitomycin) for pyelocalyceal solution

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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).

Primary outcome measure(s)

Rate of CR or no evidence of disease (NED) at first evaluation post-treatment — 3 months

Trial sites (22)

Facility	City	Region	Status
Providence St. Johns Health Center	Santa Monica	California	Recruiting
University of Florida	Gainesville	Florida	Recruiting
Mount Sinai Medical Center of Florida, Inc.	Miami	Florida	Recruiting
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.	Tampa	Florida	Recruiting
Northwestern University	Chicago	Illinois	Recruiting
Indiana University	Indianapolis	Indiana	Recruiting
The State University of Iowa	Iowa City	Iowa	Recruiting
Chesapeake Urology	Baltimore	Maryland	Recruiting
Johns Hopkins Medical Center	Baltimore	Maryland	Recruiting
Mass General Hospital (MGH)	Boston	Massachusetts	Recruiting
The Brigham and Womens Hospital	Boston	Massachusetts	Recruiting
University of Michigan	Ann Arbor	Michigan	Recruiting
University of Missouri	Columbia	Missouri	Recruiting
Rutgers	New Brunswick	New Jersey	Recruiting
The Feinstein Institutes for Medical Research	Lake Success	New York	Recruiting
NYU Grossman School of Medicine	New York	New York	Recruiting
SUNY Upstate	Syracuse	New York	Recruiting
The University of North Carolina Chapel Hill	Chapel Hill	North Carolina	Recruiting
Ohio State University	Columbus	Ohio	Recruiting
Medical University of South Carolina	Charleston	South Carolina	Recruiting
UT Southwestern Medical Center	Dallas	Texas	Recruiting
The University of Texas M.D. Anderson Cancer Center	Houston	Texas	Recruiting

More UroGen Pharma Ltd. trials in the USA

A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer Recruiting

A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer Active, not recruiting

A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer Active, not recruiting

Other trials for the same condition

A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT Active, not recruiting

GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors Recruiting

Study to Evaluate LB-LR1109, Administered Alone for the Treatment of Solid Tumor and in Combination With Atezolizumab for the Treatment of NSCLC Recruiting

A Multicenter Cancer Biospecimen Collection Study Recruiting

Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05874921 on ClinicalTrials.gov ↗ ← All trials in the USA