Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

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

Phase

2

Condition

Red Blood Cell Disorders

Post-polycythemia Vera Myelofibrosis

Myelofibrosis

Treatment

N/A

Clinical Study ID

NCT04878003
KRT-232-114
  • Ages > 18
  • All Genders

Study Summary

This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF)

The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Stage 2 will expand enrollment in Arm 1 and/or Arm 2 if expansion criteria is met.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
  • High-risk, or intermediate-1 and 2 risk, defined by Dynamic International PrognosticSystem (DIPSS)
  • ECOG of 0 or 1

Exclusion

Exclusion Criteria:

  • Subjects who are positive for p53 mutation (Arm 1)
  • Prior MDM2 inhibitor therapy or p53-directed therapy (Arm 1)
  • Prior treatment with any JAK inhibitor
  • Prior splenectomy
  • Splenic irradiation within 24 weeks prior to randomization
  • Prior allogeneic stem-cell transplantation or plans for allogeneic stem-celltransplant
  • History of major organ transplant
  • Grade 2 or higher QTc prolongation
  • Major hemorrhage or intracranial hemorrhage within 24 weeks prior to randomization

Study Design

Total Participants: 52
Study Start date:
April 13, 2021
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Republican Scientific Practical Center of Radiation Medicine and Human Ecology

    Belarus, 246040
    Belarus

    Active - Recruiting

  • Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology

    Minsk, 220045
    Belarus

    Active - Recruiting

  • UMHAT Georgi Stranski

    Pleven, 5800
    Bulgaria

    Active - Recruiting

  • Medical Centre Hipokrat N

    Plovdiv, 4000
    Bulgaria

    Active - Recruiting

  • Military Medical Academy

    Sofia, 1606
    Bulgaria

    Active - Recruiting

  • Specialized Hospital for Active Treatment of Hematologic Diseases

    Sofia, 1756
    Bulgaria

    Active - Recruiting

  • UMHAT Sv. Ivan Rilski EAD

    Sofia, 1431
    Bulgaria

    Active - Recruiting

  • JSC EVEX Hospitals

    Kutaisi, 4600
    Georgia

    Active - Recruiting

  • K.Eristavi National Center of Experimental and Clinical Surgery

    Tbilisi, 159
    Georgia

    Active - Recruiting

  • LTD M.Zodelava Hematology Centre

    Tbilisi, 112
    Georgia

    Active - Recruiting

  • Centro de Investigacion Medica Aquascalientes (CIMA)

    Aguascalientes, 20116
    Mexico

    Active - Recruiting

  • Unidad de Investigacion CIMA SC

    Chihuahua, 31200
    Mexico

    Active - Recruiting

  • Centro de Investigacion Clinica de Oaxaca (CICLO)

    Oaxaca, 68020
    Mexico

    Active - Recruiting

  • Sociedad de Metabolismo Y Corazon - SOMECO

    Veracruz, 91900
    Mexico

    Active - Recruiting

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich

    Katowice, 40-519
    Poland

    Active - Recruiting

  • Szpital Wojewodzki w Opolu Sp. z o.o., Oddzial Hematologii i Onkologii Hematologicznej

    Opole, 45-061
    Poland

    Active - Recruiting

  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.

    Słupsk, 76-200
    Poland

    Active - Recruiting

  • Botkin City Clinical Hospital

    Moscow, 125284
    Russian Federation

    Active - Recruiting

  • Republican Hospital n.a. V.A. Baranov

    Petrozavodsk, 185019
    Russian Federation

    Active - Recruiting

  • Almazov National Medical Research Center

    Saint Petersburg, 197341
    Russian Federation

    Active - Recruiting

  • Almazov National Medical Research Centre

    Saint Petersburg, 197341
    Russian Federation

    Active - Recruiting

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, 197022
    Russian Federation

    Active - Recruiting

  • Samara State Medical University

    Samara, 443099
    Russian Federation

    Active - Recruiting

  • Wits Baragwanath Clinical Hematology Department

    Soweto, 1519
    South Africa

    Active - Recruiting

  • City Hematology Center of Municipal Non-Profit Enterprise City Clinical Hospital #4 of Dnipro City Council

    Dnipro, 49102
    Ukraine

    Active - Recruiting

  • Innovative Clinical Research Institute

    Glendale, California 90603
    United States

    Active - Recruiting

  • Innovative Clinical Research Institute

    Whittier, California 90603
    United States

    Active - Recruiting

  • Gabrail Cancer Center

    Canton, Ohio 44718
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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