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NCT05874921 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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