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

November 28, 2023 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
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
        • Contact:
          • Brett Johnson, MD

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:

  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

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
CR rate 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

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, 2025

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 (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UT004

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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