uTRACT Jelmyto Registry: A Registry of Patients With Uppe... | NCT05874921

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

NCT05874921

Sponsor

UroGen Pharma Ltd.

Status

Recruiting

Last Update Posted

Feb 28, 2025Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

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

Interventions

Jelmyto (mitomycin) for pyelocalyceal solution

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 17, 2023Actual

Primary Completion Date

Apr 2026Estimated

Completion Date

Jan 2028Estimated

First Submitted Date

Dec 22, 2022

First Submission Date that Met QC Criteria

May 22, 2023

First Posted Date

May 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2025

Last Update Posted Date

Feb 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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:

How is Jelmyto used in the real world setting?
What adverse events (AEs) and at what rates and time points are they observed in the real world setting?
What is the disease volume before and after resection/ablation prior to treating with Jelmyto?
Did the use of Jelmyto impact clinical decision making and management?
What is the complete response (CR) rate, duration of response, and rate of progression, including subgroups of interest?
What are the rates of, time to, and pathology at radical nephroureterectomy (RNU) by response to treatment and number of Jelmyto doses received?
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?
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?
What is the rate and timing of bladder cancer occurrence and/or recurrences?

Conditions Module

Conditions

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Jelmyto		Patients with UTUC treated with Jelmyto	Drug: Jelmyto (mitomycin) for pyelocalyceal solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Jelmyto (mitomycin) for pyelocalyceal solution	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of CR or no evidence of disease (NED) at first evaluation post-treatment		3 months

Secondary Outcomes

Measure	Description	Time Frame
Duration of response		3 years
Rate of progression		3 years
Rates and clinical significance of AEs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with UTUC who have been treated, are currently undergoing treatment, or will be treated with JELMYTO.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Louie, MD, MPH, MSc	Contact	855-987-6436		registry@urogen.com

Overall Officials

Name	Affiliation	Role
Yair Lotan, MD	UT Southwestern Medical Center at Dallas	Principal Investigator
Adam Feldman, MD	Massachusett&#39;s General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Providence St. Johns Health Center	Recruiting	Santa Monica	California	90404	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D002295	Carcinoma, Transitional Cell
D002277	Carcinoma
D012008	Recurrence
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Ancestor Terms

ID	Term
D009375	Neoplasms, Glandular and Epithelial
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D014570	Urologic Diseases

ID	Term
D016685	Mitomycin

Ancestor Terms

ID	Term
D008937	Mitomycins
D045563	Indolequinones
D011809	Quinones
D009930	Organic Chemicals
D001389	Azirines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring