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

Last updated: May 5, 2022
Sponsor: Kartos Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Myelofibrosis

Post-polycythemia Vera Myelofibrosis

Thrombosis

Treatment

N/A

Clinical Study ID

NCT04485260
KRT-232-109
  • Ages 18-99
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treatingphysician according to the World Health Organization (WHO)
  • Treatment with ruxolitinib for ≥18 weeks prior to study entry, and on a stable dose ofruxolitinib 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

Exclusion

Exclusion Criteria:

  • Patients who are positive for TP53 mutations
  • Documented disease progression or clinical deterioration any time while on ruxolitinibtreatment
  • Patients who have had a documented spleen response to ruxolitinib.
  • Prior splenectomy
  • Prior MDM2 inhibitor therapy or p53-directed therapy

Study Design

Total Participants: 36
Study Start date:
January 28, 2021
Estimated Completion Date:
October 31, 2024

Connect with a study center

  • Royal Adelaide Hospital

    Adelaide,
    Australia

    Active - Recruiting

  • Dr. Georgi Stranski

    Pleven,
    Bulgaria

    Active - Recruiting

  • Saint Ivan Rilski Hospital

    Sofia, 1431
    Bulgaria

    Active - Recruiting

  • University Mutiprofile Hospital Alexandrovska

    Sofia, 1431
    Bulgaria

    Active - Recruiting

  • CHU de Caen

    Caen, Cedex 9 14033
    France

    Active - Recruiting

  • Chu Angers

    Angers, 49933
    France

    Active - Recruiting

  • Centre Hospitalier du Mans

    Le Mans, 72000
    France

    Active - Recruiting

  • Institut Paoli-Calmettes

    Marseille, 13009
    France

    Active - Recruiting

  • CHU Saint Eloi

    Montpellier, 34295
    France

    Active - Recruiting

  • Hopital Saint Louis

    Paris,
    France

    Active - Recruiting

  • CHU Tours - Hôpital Bretonneau

    Tours,
    France

    Active - Recruiting

  • Universitätsklinikum Aachen Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation

    Aachen, 52074
    Germany

    Active - Recruiting

  • Department für Innere Medizin Universitätsklinik und Poliklinik für Innere Medizin IV Hämatologie/Onkologie

    Halle, 6120
    Germany

    Active - Recruiting

  • Universitaetsklinikum Jena

    Jena,
    Germany

    Active - Recruiting

  • UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz III. Med. Klinik und Poliklinik

    Mainz, 55131
    Germany

    Active - Recruiting

  • Stauferklinikum Schwäbisch Gmünd

    Mutlangen, 73557
    Germany

    Active - Recruiting

  • Shamir Medical Center ( Assaf Harofeh)

    Zerifin, 7033001
    Israel

    Active - Recruiting

  • Bologna University Hospital, Institute of Hematology

    Bologna, 340136
    Italy

    Active - Recruiting

  • Universita degli Studi di Catania

    Catania, 95124
    Italy

    Active - Recruiting

  • University of Florence

    Firenze, 50134
    Italy

    Active - Recruiting

  • Istituto Tumori della Romagna (IRST)

    Meldola, 47014
    Italy

    Active - Recruiting

  • Ospedale di Circolo e Fondazione MacchiASST Sette Laghi

    Varese, 21100
    Italy

    Active - Recruiting

  • Oddział Kliniczny Hematologii Szpitala Uniwersyteckiego w Krakowie

    Kraków,
    Poland

    Active - Recruiting

  • Szpital Wojewódzki w Opolu Sp zooOddzial Kliniczny Hematologii

    Opole,
    Poland

    Active - Recruiting

  • Hospital Universitario Germans Trias i Pujol

    Barcelona, 08916
    Spain

    Active - Recruiting

  • d'Hebron University Hospital in Barcelona

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario de Gran Canaria Doctor Negrin

    Las Palmas De Gran Canaria,
    Spain

    Active - Recruiting

  • Hospital Virgen de la Victoria

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital Universitario de Salamanca

    Salamanca,
    Spain

    Active - Recruiting

  • Hospital de Dia Quiron Zaragoza

    Zaragoza, 50012
    Spain

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • John Hopkins University

    Baltimore, Maryland 21205
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

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