PRT12396 for people with high-risk polycythemia vera or myelofibrosis

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

This first-in-human, open-label, multi-center Phase 1 program tests oral PRT12396 in adults with high-risk polycythemia vera or myelofibrosis, including post-PV and post-ET MF with splenomegaly and documented JAK2 V617 mutation. Part 1 uses dose escalation to define safety, tolerability, pharmacokinetics, and the maximum tolerated dose (MTD) and recommended dose(s) for expansion; Part 2 enrolls additional participants at selected doses to further characterize safety and preliminary efficacy. Approximately up to 100 participants will be enrolled across both parts, with regular clinic visits, laboratory monitoring, and imaging to track spleen size, blood counts, adverse events, and drug levels. Participants must meet organ function, performance status, contraception, and other standard eligibility requirements.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures.
* Confirmed diagnosis of PV or MF according to WHO 2016 or revised ICC/WHO 2022 criteria
* Documented presence of a JAK2 V617 mutation
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Estimate life expectancy of ≥12 weeks per investigator assessment.
* Negative serum or urine pregnancy test and agree to use contraception or maintain true abstinence.
* Adequate organ function and bone marrow reserves (hematology, renal, and hepatic)

Exclusion Criteria:

* History of another malignancy within 3 years prior to enrollment, except for malignancy considered cured with low risk of recurrence.
* Clinically significant anemia due to nutritional deficiency or hemolytic disorders.
* Active or uncontrolled infection requiring systemic therapy or hospitalization.
* Any other medical or psychiatric conditions that, in the Investigator's judgment, would increase risk or interfere with study participation or interpretation of results.
* Clinically significant or uncontrolled medical conditions, including active infection or cardiovascular disease, that would increase risk or interfere with study participation.
* Unresolved toxicity Grade \>1 from prior anticancer therapy, except for alopecia or peripheral neuropathy Grade ≤2.
* Pregnancy or breastfeeding
* Known sensitivity or contraindication to any component of study, or the excipients of study treatment.
* Prior systemic therapy for PV or MF, prior or planned allogeneic hematopoietic stem-cell transplantation, recent major surgery, prior splenectomy or prior splenic irradiation, or use of hematopoietic growth factors within protocol-defined washout periods.
* Use of strong or moderate cytochrome P450 (CYP) 3A4 inhibitor or inducer, sensitive CYP3A substrates with narrow therapeutic range, or acid-reducing agents that cannot be discontinued prior to study treatment.
* Participation in another interventional clinical study.

Where it's running

• UCLA Ronald Reagan Medical Center
  Los Angeles, California, United States Recruiting
• University of California, Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting
• Colorado Blood Cancer Institute
  Denver, Colorado, United States Recruiting
• BRCR Global - Coral Springs
  Coral Springs, Florida, United States Recruiting
• Sylvester Comprehensive Cancer Center
  Miami, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting

Study contacts

• Study coordinator: Study Contact (Please Do Not Disclose Personal Information)
• Email: clinicaltrials@preludetx.com
• Phone: See Email

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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.