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

NCT05874921 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-02-28

No results posted yet for this study

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.

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

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.

Sponsors & Collaborators

  • UroGen Pharma Ltd.

    lead INDUSTRY

Principal Investigators

  • Yair Lotan, MD · UT Southwestern Medical Center at Dallas

  • Adam Feldman, MD · Massachusett's General Hospital

  • Solomon Woldu, MD · UT Southwestern Medical Center at Dallas

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-17
Primary Completion
2026-04-30
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05874921 on ClinicalTrials.gov