Carcinoma, Transitional Cell, Transitional Cell Carcinoma of Renal Pelvis, Urothelial Cancer of Renal Pelvis, Urothelial Carcinoma, Urothelial Carcinoma of the Renal Pelvis and Ureter, Urothelial Carcinoma Recurrent, Urothelial Carcinoma Ureter, Urothelial Carcinoma Ureter Recurrent
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
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.
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?
Interventions
DRUGJelmyto (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.
Sponsors
UroGen Pharma Ltd.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of CR or no evidence of disease (NED) at first evaluation post-treatment | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response | 3 years |
| Rate of progression | 3 years |
| Rates and clinical significance of AEs | 3 years |
Countries
United States
Contacts
Primary ContactMichael Louie, MD, MPH, MSc
Outcome results
None listed