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

Urothelial Carcinoma Clinical Trial

— uTRACT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05874921
• Other study ID #: UT004
• Status: Recruiting
• Start date: November 17, 2023
• Est. completion date: January 2028

Study information

• Verified date: November 2023
• Source: UroGen Pharma Ltd.
• Contact: Anthony Fernandez, PharmD
• Phone: +1 954-482-3576
• Email: registry[@]urogen.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 2028
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of UTUC

2. Meet at least one of the following criteria:

• Have been treated with Jelmyto after April 2020

• Currently undergoing treatment with Jelmyto

• Will receive Jelmyto

Exclusion Criteria: None

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
UroGen Pharma Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CR rate at first evaluation post-treatment		3 months
Secondary	Duration of response		3 years
Secondary	Rate of progression		3 years
Secondary	Rates and clinical significance of AEs		3 years