NCT05874921

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

uTRACT Jelmyto Registry: A Multicenter, Prospective and Retrospective Registry to Evaluate Real World Experience and Outcomes of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: UroGen Pharma Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

Conditions

• Urothelial Carcinoma
• Urothelial Carcinoma Recurrent
• Urothelial Carcinoma Ureter
• Urothelial Carcinoma Ureter Recurrent
• Urothelial Cancer of Renal Pelvis
• Urothelial Carcinoma of the Renal Pelvis and Ureter
• Carcinoma, Transitional Cell
• Transitional Cell Carcinoma of Renal Pelvis

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2023-11-17
• Primary completion: 2026-04-01
• Completion: 2028-01-01
• First posted: 2023-05-25
• Last updated: 2025-02-28

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study