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

ConditionsUrothelial CarcinomaUrothelial Carcinoma RecurrentUrothelial Carcinoma UreterUrothelial Carcinoma Ureter RecurrentUrothelial Cancer of Renal PelvisUrothelial Carcinoma of the Renal Pelvis and UreterCarcinoma, Transitional CellTransitional Cell Carcinoma of Renal Pelvis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUroGen Pharma Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • 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.

Treatment groups

450 Participants
are divided into 1 treatment group
Group A: Jelmyto1 intervention

Trial outcomes

Primary outcomes

1

Rate of No Evidence of Disease (NED) at first evaluation post-treatment (investigator assessment)

To evaluate the tumor ablative effect of JELMYTO in the Registry population

Time frame
3 months

Secondary outcomes

1

Durability of response at 12, 24, and 36 months in patients who achieve NED after primary treatment with JELMYTO.

To evaluate response to JELMYTO treatment in the Registry population

Time frame
3 years
2

Recurrence free survival after adjuvant treatment with JEMLYTO

To evaluate response to JELMYTO treatment in the Registry population

Time frame
3 years
3

Time to recurrence

To evaluate response to JELMYTO treatment in the Registry population

Time frame
3 years
4

Time to progression

To evaluate response to JELMYTO treatment in the Registry population

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UroGen Pharma Ltd.

Lead sponsor

Source ClinicalTrials.gov
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