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

February 25, 2025 updated by: UroGen Pharma Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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?

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
    • Florida
      • Gainesville, Florida, United States, 32610
      • Miami, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Medical Center of Florida, Inc.
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.
        • Contact:
    • Illinois
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Medical Center
        • Contact:
          • Nirmish Singla, MD
          • Phone Number: 410-955-6100
      • Baltimore, Maryland, United States, 21204
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Mass General Hospital (MGH)
        • Contact:
      • Boston, Massachusetts, United States, 02115
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
    • Missouri
      • Columbia, Missouri, United States, 65211
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • The Feinstein Institutes for Medical Research
        • Contact:
      • New York, New York, United States, 10016
      • Syracuse, New York, United States, 13210
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
    • Ohio
      • Columbus, Ohio, United States, 43202
        • Recruiting
        • Ohio State University
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75390
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas M.D. Anderson Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Jelmyto
Patients with UTUC treated with Jelmyto
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.

Other Names:
  • UGN-101
  • Jelmyto

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UroGen Pharma Ltd.

Investigators

  • Principal Investigator: Yair Lotan, MD, UT Southwestern Medical Center at Dallas
  • Principal Investigator: Adam Feldman, MD, Massachusett's General Hospital
  • Principal Investigator: Solomon Woldu, MD, UT Southwestern Medical Center at Dallas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2023

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UT004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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