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

Sponsor

UroGen Pharma Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05874921

Collaborator

(none)

400

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: Jelmyto (mitomycin) for pyelocalyceal solution

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:

How is Jelmyto used in the real world setting?
What adverse events (AEs) and at what rates and time points are they observed in the real world setting?
What is the disease volume before and after resection/ablation prior to treating with Jelmyto?
Did the use of Jelmyto impact clinical decision making and management?
What is the complete response (CR) rate, duration of response, and rate of progression, including subgroups of interest?
What are the rates of, time to, and pathology at radical nephroureterectomy (RNU) by response to treatment and number of Jelmyto doses received?
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?
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?
What is the rate and timing of bladder cancer occurrence and/or recurrences?

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Jul 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Jelmyto 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. Other Names: Jelmyto UGN-101

Arm

Intervention/Treatment

Jelmyto

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.

Other Names:

Jelmyto

UGN-101