An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With Ruxolitinib in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post ET-MF) Who Have a Suboptimal Response to Ruxolitinib
Status unconfirmed · Phase 1/Phase 2
Conditions studied: Myelofibrosis
In brief
This is a phase 1b/2 study of KRT-232 combined with ruxolitinib in subjects with MF who have a suboptimal response after at least 18 weeks of treatment with ruxolitinib. The primary objective of the study is to determine a recommended phase 2 dose (RP2D) of KRT 232 in combination with ruxolitinib.
Key facts
- Study ID
- NCT04485260
- Run by
- Kartos Therapeutics, Inc.
- People needed
- 36
- Starts
- 2021-01-28
- Expected to finish
- 2024-10-01
- Last updated by the study team
- 2022-05-09
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO)
- Treatment with ruxolitinib for ≥18 weeks prior to study entry, and on a stable dose of ruxolitinib in the 8 weeks prior to study entry
- Spleen ≥5 cm palpable below the LLCM or ≥450 cm3 by MRI or CT
- Patients must have at least 2 symptoms with a score of at least 1 on the MFSAF v4.0
- ECOG performance status of 0 to 2
You may not qualify if…
- Patients who are positive for TP53 mutations
- Documented disease progression or clinical deterioration any time while on ruxolitinib treatment
- Patients who have had a documented spleen response to ruxolitinib.
- Prior splenectomy
- Prior MDM2 inhibitor therapy or p53-directed therapy
Where it is running
- City of Hope — Duarte, California, United States (enrolling)
- John Hopkins University — Baltimore, Maryland, United States (enrolling)
- University of Michigan — Ann Arbor, Michigan, United States (enrolling)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Fred Hutchinson Cancer Research Center — Seattle, Washington, United States (enrolling)
- Royal Adelaide Hospital — Adelaide, Australia (enrolling)
- Dr. Georgi Stranski — Pleven, Bulgaria (enrolling)
- Saint Ivan Rilski Hospital — Sofia, Bulgaria (enrolling)
- University Mutiprofile Hospital Alexandrovska — Sofia, Bulgaria (enrolling)
- CHU de Caen — Caen, Cedex 9, France (enrolling)
- Chu Angers — Angers, France (enrolling)
- Centre Hospitalier du Mans — Le Mans, France (enrolling)
- Institut Paoli-Calmettes — Marseille, France (enrolling)
- CHU Saint Eloi — Montpellier, France (enrolling)
- Hopital Saint Louis — Paris, France (enrolling)
- CHU Tours - Hôpital Bretonneau — Tours, France (enrolling)
- Universitätsklinikum Aachen Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation — Aachen, Germany (enrolling)
- Department für Innere Medizin Universitätsklinik und Poliklinik für Innere Medizin IV Hämatologie/Onkologie — Halle, Germany (enrolling)
- Universitaetsklinikum Jena — Jena, Germany (enrolling)
- UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz III. Med. Klinik und Poliklinik — Mainz, Germany (enrolling)
- Stauferklinikum Schwäbisch Gmünd — Mutlangen, Germany (enrolling)
- Shamir Medical Center ( Assaf Harofeh) — Ẕerifin, Israel (enrolling)
Full record on ClinicalTrials.gov
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