Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Recurrence

Carcinoma, Transitional Cell

Urologic Neoplasms

Urogenital Neoplasms

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Disease Attributes

Transitional Cell Carcinoma

Pharmaceutical Solutions

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Mitomycins

Mitomycin

Enzyme Inhibitors

Alkylating Agents

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.

Jelmyto (mitomycin) for pyelocalyceal solution

Anthony Fernandez, PharmD

Brett Johnson, MD

Yair Lotan, MD

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.

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?

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

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

UroGen Pharma Ltd.

Mitomycin for pyelocalyceal solution

Michael Louie, MD, MPH, MSC

This program provides controlled, pre-approval access to JELMYTO in response to unsolicited requests by physicians, hospitals, pharmacies, distributors, ministries of health or other parties on behalf of specific, or named patients, in select countries where JELMYTO has not yet received a marketing authorization and in situations when patients have exhausted all available treatment options.

Named Patient Program for Mitomycin for Pyelocalyceal Solution

Tanner Pharma Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto	NCT05874921	Urothelial Carc... Urothelial Carc... Urothelial Carc... Urothelial Carc... Urothelial Canc... Urothelial Carc... Carcinoma, Tran... Transitional Ce...	Jelmyto (mitomy...	18 Years -	UroGen Pharma Ltd.
Named Patient Program for Mitomycin for Pyelocalyceal Solution	NCT05494411	Urothelial Canc... Urothelial Carc... Urothelial Carc... Urothelial Carc... Urothelial Carc... Urothelial Carc...	Mitomycin for p...	18 Years -	UroGen Pharma Ltd.
Named Patient Program for Mitomycin for Pyelocalyceal Solution	NCT05494411	Urothelial Canc... Urothelial Carc... Urothelial Carc... Urothelial Carc... Urothelial Carc... Urothelial Carc...	Mitomycin for p...	18 Years -	UroGen Pharma Ltd.

Spots Global Cancer Trial Database for urothelial carcinoma ureter recurrent