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

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

NCT ID: NCT05874921

Condition: 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

Conditions: Official terms:
Carcinoma
Carcinoma, Transitional Cell
Recurrence
Mitomycins
Mitomycin

Conditions: Keywords:
Upper Tract Urothelial Cancer
UTUC
UGN-101
Mitomycin C
TCC
Ureteral
Upper Tract
Carcinoma
Kidney
Renal
Gel
Local
Prolonged Release
Slow Release
Kidney Sparing
Recurrence
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Other

Intervention:

Intervention type: Drug
Intervention name: Jelmyto (mitomycin) for pyelocalyceal solution
Description: 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.
Arm group label: Jelmyto

Other name: Jelmyto

Other name: UGN-101

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.

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: 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?

Criteria for eligibility:

Study pop:
Patients with UTUC who have been treated, are currently undergoing treatment, or will be treated with Jelmyto.

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: UT Southwestern Medical Center

Address:
City: Dallas
Zip: 75390
Country: United States

Status: Recruiting

Contact:
Last name: Brett Johnson, MD

Start date: November 17, 2023

Completion date: January 2028

Lead sponsor:
Agency: UroGen Pharma Ltd.
Agency class: Industry

Source: UroGen Pharma Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05874921