KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera (NCT03669965)
A Two-Part, Randomized, Open-label, Multicenter, Phase 2a/2b Study of the Efficacy, Safety, and Pharmacokinetics of KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera
🩺 Plain-English Summary (8th-Grade Level)
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with phlebotomy-dependent polycythemia vera (PV). Inhibition of MDM2 in PV is a new mechanism of action in PV. In Part A, patients must be resistant or intolerant to hydroxyurea or have undergone treatment with interferon. In Part B, patients must be resistant or intolerant to hydroxyurea. This study is a global, open-label Phase 2a/2b study to determine the efficacy and safety of KRT-232. In Part A of the study, patients will be randomly assigned to 5 arms with 2 different doses and 3 different dosing schedules of KRT 232. In Part B of the study, patients will be randomized either to treatment with KRT-232 administered at the recommended dose and schedule from Part A or to treatment with ruxolitinib.
Who can join: Review the eligibility criteria below.
Location: The Kirklin Clinic of UAB Hospital — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (16 Sites)
- The Kirklin Clinic of UAB Hospital — Birmingham, Alabama
- University of Southern California Norris Comprehensive Cancer Center — Los Angeles, California
- Washington University School of Medicine — St Louis, Missouri
- Gabrail Cancer Center — Canton, Ohio
- The Ohio State University Comprehensive Cancer Center — Columbus, Ohio
- Center Hospitalier Universitaire d'Angers — Angers,
- Universitätsklinikum Aachen — Aachen, North Rhine-Westphalia
- Gemeinschaftspraxis Haematologie - Onkologie - Hauptstelle — Dresden, Saxony
- Universitätsklinikum Carl Gustav Carus — Dresden, Saxony
- Stauferklinikum Schwäbisch Gmünd — Mutlangen,
- Békés Megyei Központi Kórház Pándy Kálmán Tagkórház — Gyula,
- Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku — Wroclaw, Lower Silesian Voivodeship
- Szpital Wojewódzki w Opolu — Opole,
- Hospital Universitario de Gran Canaria Doctor Negrin — Las Palmas de Gran Canaria, LAS Palmas
- Hospital Universitario Virgen de la Victoria — Málaga,
- Hospital Universitario de Salamanca — Salamanca,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Polycythemia Vera
- A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera — Mobile, Alabama
- Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera — Covington, Louisiana
- Study to Assess SLN124 in Patients With Polycythemia Vera — Hammond, Louisiana
- A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV — Jacksonville, Florida
- A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes — Rochester, Minnesota
Explore by condition: All Polycythemia Vera clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.