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

UroGen Pharma

Status: Enrolling

Conditions: Urothelial Carcinoma Ureter; Urothelial Carcinoma Recurrent; Urothelial Carcinoma; Carcinoma, Transitional Cell; Urothelial Carcinoma of the Renal Pelvis and Ureter; Urothelial Carcinoma Ureter Recurrent; Urothelial Cancer of Renal Pelvis; Transitional Cell Carcinoma of Renal Pelvis

Treatments: Drug: Jelmyto (mitomycin) for pyelocalyceal solution

Study type: Observational

Funder types: Industry

Identifiers

NCT05874921

UT004

Details and patient eligibility

About

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.

Full 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?

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

400 participants in 1 patient group

Jelmyto

Description:

Patients with UTUC treated with Jelmyto

Treatment:

Drug: Jelmyto (mitomycin) for pyelocalyceal solution