Alpha1H before bladder tumor surgery in low/intermediate risk non-muscle-invasive bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with low- to intermediate-risk non-muscle-invasive bladder cancer will be randomly assigned to receive bladder-sprayed Alpha1H before TURBT surgery or standard care alone. Those in the Alpha1H arm will receive six intravesical doses over about one month with up to two hours of bladder retention per session, followed by standard TURBT. The study aims to see if Alpha1H can lower recurrence or progression and to evaluate safety and tolerability. The trial uses a randomized, controlled design to compare pre-surgery Alpha1H plus TURBT versus TURBT with standard care. Lead sponsor is Hamlet Pharma AB, with sites in Prague, Czechia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signed and dated informed consent.
* Low- or intermediate-risk non-muscle-invasive bladder cancer (NMIBC) meeting one of the following definitions:
* Low-risk NMIBC: Primary, solitary, Ta, low-grade, 0.5 cm to 3 cm.
* Intermediate-risk NMIBC (low-to-intermediate risk subgroup per IBCG classification):
* Primary multifocal (\<10 lesions), Ta, low-grade, 0.5 cm to 3 cm;
* Recurrent solitary, Ta, low-grade, 0.5 cm to 3 cm; or
* Recurrent multifocal (\<10 lesions), Ta, low-grade, \>1 year after previous recurrence.
* Men and women aged 18 years or older.
* Negative pregnancy test at screening for women of childbearing potential.
* Women of childbearing potential must agree to use highly effective contraception methods throughout study participation; men of childbearing potential must refrain from donating sperm during the study.
* Ability to retain bladder contents for 2 hours.

Exclusion Criteria:

* Patient with non-papillary tumor appearance at the time of initial cystoscopy.
* Previous history of T1 or high-grade disease in recurrent tumors.
* Patients with T1 or high-grade non-muscle invasive papillary bladder cancer (NMIBC).
* Previous intravesical BCG immunotherapy.
* Patients with any other cancer diagnosis within the last 5 years (except for skin basalioma).
* Acute urinary tract infection requiring antibiotic treatment.
* Prior radiotherapy or systemic chemotherapy.
* WHO performance status of 3 or 4.
* Any other investigational agent or non-marketed product within one month prior to Visit 1 and during the trial.
* Known active HIV infection, defined as detectable HIV viral load at screening.
* Active hepatitis B virus (HBV) infection, defined as hepatitis B surface antigen (HBsAg) positivity with detectable HBV DNA at screening.
* Active hepatitis C virus (HCV) infection, defined as anti-HCV antibody positivity with detectable HCV RNA at screening in a patient not on stable antiviral treatment.
* Any concurrent illness that may render a participant ineligible or limit compliance with study requirements.
* Previously enrolled in this trial.

Where it's running

• Fakultni nemocnice Motol a Homolka
  Prague, Czechia Recruiting

Study contacts

• Study coordinator: Catharina Svanborg, MD, PhD.
• Email: catharina.svanborg@med.lu.se
• Phone: +46709426549

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.