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

Recruiting

• Conditions: Urothelial Carcinoma; Urothelial Carcinoma Ureter Recurrent; Urothelial Carcinoma of the Renal Pelvis and Ureter; Urothelial Carcinoma Recurrent; Urothelial Carcinoma Ureter; Urothelial Cancer of Renal Pelvis; Transitional Cell Carcinoma of Renal Pelvis; Carcinoma, Transitional Cell
• Interventions: Drug: Jelmyto (mitomycin) for pyelocalyceal solution

• Registration Number: NCT05874921
• Lead Sponsor: UroGen Pharma Ltd.

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.

Detailed Description

Patients may be enrolled prospectively, at the time of receiving Jelmyto, or after receiving Jelmyto for retrospective data capture and prospective follow up. Patients will be followed until 3 years after the first dose of Jelmyto or death.

Data will be captured to address specific clinical questions and data gaps related to real world use of Jelmyto.

Example clinical questions:

1. How is Jelmyto used in the real world setting?

2. What adverse events (AEs) and at what rates and time points are they observed in the real world setting?

3. What is the disease volume before and after resection/ablation prior to treating with Jelmyto?

4. Did the use of Jelmyto impact clinical decision making and management?

5. What is the complete response (CR) rate, duration of response, and rate of progression, including subgroups of interest?

6. What are the rates of, time to, and pathology at radical nephroureterectomy (RNU) by response to treatment and number of Jelmyto doses received?

7. What are outcomes for non-responders or partial responders? What are the rates of surgical and therapeutic treatment options received following response assessment, including additional Jelmyto?

8. What was the outcome of patients with solitary kidney and/or chronic kidney disease (CKD)? Did Jelmyto prevent dialysis by avoiding nephrectomy in solitary kidney or in patients with baseline CKD?

9. What is the rate and timing of bladder cancer occurrence and/or recurrences?

Study Timeline

• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-05-25
• Study Start: 2023-11-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28
• Primary Completion: 2026-04
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Jelmyto	Jelmyto (mitomycin) for pyelocalyceal solution	Patients with UTUC treated with Jelmyto

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rate of progression	3 years
Rates and clinical significance of AEs	3 years
Duration of response	3 years

Trial Locations

Locations (22)

The State University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Chesapeake Urology; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Medical Center; 🇺🇸 Baltimore, Maryland, United States

Mass General Hospital (MGH); 🇺🇸 Boston, Massachusetts, United States

Providence St. Johns Health Center; 🇺🇸 Santa Monica, California, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Mount Sinai Medical Center of Florida, Inc.; 🇺🇸 Miami, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.; 🇺🇸 Tampa, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

The Brigham and Womens Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of Missouri; 🇺🇸 Columbia, Missouri, United States

Rutgers; 🇺🇸 New Brunswick, New Jersey, United States

The Feinstein Institutes for Medical Research; 🇺🇸 Lake Success, New York, United States

NYU Grossman School of Medicine; 🇺🇸 New York, New York, United States

SUNY Upstate; 🇺🇸 Syracuse, New York, United States

The University of North Carolina Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

The University of Texas M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States