An observational study in Urothelial Carcinoma, Urothelial Carcinoma Recurrent and Urothelial Carcinoma Ureter, sponsored by UroGen Pharma Ltd.. Recruiting at 22 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by UroGen Pharma Ltd. · Observational
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.
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:
Patients with UTUC who have been treated, are currently undergoing treatment, or will be treated with JELMYTO.
Exclusion Criteria:
Patients with UTUC treated with Jelmyto
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.
Also known as: Jelmyto, UGN-101
Rate of No Evidence of Disease (NED) at first evaluation post-treatment (investigator assessment)
To evaluate the tumor ablative effect of JELMYTO in the Registry population
Time frame: 3 months
Durability of response at 12, 24, and 36 months in patients who achieve NED after primary treatment with JELMYTO.
To evaluate response to JELMYTO treatment in the Registry population
Time frame: 3 years
Recurrence free survival after adjuvant treatment with JEMLYTO
To evaluate response to JELMYTO treatment in the Registry population
Time frame: 3 years
Time to recurrence
To evaluate response to JELMYTO treatment in the Registry population
Time frame: 3 years
Time to progression
To evaluate response to JELMYTO treatment in the Registry population
Time frame: 3 years
Incidence of JELMYTO-related AEs
To assess the safety of JELMYTO in the Registry population
Time frame: 3 years
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UroGen Pharma Ltd.