Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
Status unconfirmed · Phase 2
Conditions studied: Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV-MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF)
In brief
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.
Key facts
- Study ID
- NCT04878003
- Run by
- Kartos Therapeutics, Inc.
- People needed
- 52
- Starts
- 2021-04-13
- Expected to finish
- 2025-10-01
- Last updated by the study team
- 2022-05-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
- High-risk, or intermediate-1 and 2 risk, defined by Dynamic International Prognostic System (DIPSS)
- ECOG of 0 or 1
You may not qualify if…
- 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-cell transplant
- History of major organ transplant
- Grade 2 or higher QTc prolongation
- Major hemorrhage or intracranial hemorrhage within 24 weeks prior to randomization
Where it is running
- Innovative Clinical Research Institute — Glendale, California, United States (enrolling)
- Innovative Clinical Research Institute — Whittier, California, United States (enrolling)
- Gabrail Cancer Center — Canton, Ohio, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Republican Scientific Practical Center of Radiation Medicine and Human Ecology — Belarus’, Belarus (enrolling)
- Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology — Minsk, Belarus (enrolling)
- UMHAT Georgi Stranski — Pleven, Bulgaria (enrolling)
- Medical Centre Hipokrat N — Plovdiv, Bulgaria (enrolling)
- UMHAT Sv. Ivan Rilski EAD — Sofia, Bulgaria (enrolling)
- Military Medical Academy — Sofia, Bulgaria (enrolling)
- Specialized Hospital for Active Treatment of Hematologic Diseases — Sofia, Bulgaria (enrolling)
- JSC EVEX Hospitals — Kutaisi, Georgia (enrolling)
- LTD M.Zodelava Hematology Centre — Tbilisi, Georgia (enrolling)
- K.Eristavi National Center of Experimental and Clinical Surgery — Tbilisi, Georgia (enrolling)
- Centro de Investigacion Medica Aquascalientes (CIMA) — Aguascalientes, Mexico (enrolling)
- Unidad de Investigacion CIMA SC — Chihuahua City, Mexico (enrolling)
- Centro de Investigacion Clinica de Oaxaca (CICLO) — Oaxaca City, Mexico (enrolling)
- Sociedad de Metabolismo Y Corazon - SOMECO — Veracruz, Mexico (enrolling)
- Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich — Katowice, Poland (enrolling)
- Szpital Wojewodzki w Opolu Sp. z o.o., Oddzial Hematologii i Onkologii Hematologicznej — Opole, Poland (enrolling)
- Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o. — Słupsk, Poland (enrolling)
- Botkin City Clinical Hospital — Moscow, Russia (enrolling)
- Republican Hospital n.a. V.A. Baranov — Petrozavodsk, Russia (enrolling)
- Pavlov First Saint Petersburg State Medical University — Saint Petersburg, Russia (enrolling)
- Almazov National Medical Research Center — Saint Petersburg, Russia (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.