Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
An Open-Label, Multicenter, Phase 2 Study Assessing the Safety and Efficacy of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
1 other identifier
interventional
52
9 countries
29
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2021
Typical duration for phase_2
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 13, 2021
CompletedFirst Submitted
Initial submission to the registry
May 4, 2021
CompletedFirst Posted
Study publicly available on registry
May 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedMay 9, 2022
May 1, 2022
3.1 years
May 4, 2021
May 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Spleen Volume Reduction (SVR)
The proportion of subjects achieving ≥35% SVR at Week 24 by MRI/CT (central review)
24 weeks
Secondary Outcomes (5)
Improvement in Total Symptom Score (TSS)
24 weeks
Spleen Response Duration
48 months
Rate of conversion from RBC transfusion dependent to independent
24 weeks
Overall Survival (OS)
48 months
Progression free survival (PFS)
48 months
Study Arms (2)
Arm 1
EXPERIMENTALKRT-232 administered orally as 240 mg once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles
Arm 2
EXPERIMENTALTL-895 administered orally as 150 mg twice daily continuously in 28-day cycles
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Innovative Clinical Research Institute
Glendale, California, 90603, United States
Innovative Clinical Research Institute
Whittier, California, 90603, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Republican Scientific Practical Center of Radiation Medicine and Human Ecology
Belarus’, 246040, Belarus
Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology
Minsk, 220045, Belarus
UMHAT Georgi Stranski
Pleven, 5800, Bulgaria
Medical Centre Hipokrat N
Plovdiv, 4000, Bulgaria
UMHAT Sv. Ivan Rilski EAD
Sofia, 1431, Bulgaria
Military Medical Academy
Sofia, 1606, Bulgaria
Specialized Hospital for Active Treatment of Hematologic Diseases
Sofia, 1756, Bulgaria
JSC EVEX Hospitals
Kutaisi, 4600, Georgia
LTD M.Zodelava Hematology Centre
Tbilisi, 112, Georgia
K.Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, 159, Georgia
Centro de Investigacion Medica Aquascalientes (CIMA)
Aguascalientes, 20116, Mexico
Unidad de Investigacion CIMA SC
Chihuahua City, 31200, Mexico
Centro de Investigacion Clinica de Oaxaca (CICLO)
Oaxaca City, 68020, Mexico
Sociedad de Metabolismo Y Corazon - SOMECO
Veracruz, 91900, Mexico
Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich
Katowice, 40-519, Poland
Szpital Wojewodzki w Opolu Sp. z o.o., Oddzial Hematologii i Onkologii Hematologicznej
Opole, 45-061, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
Słupsk, 76-200, Poland
Botkin City Clinical Hospital
Moscow, 125284, Russia
Republican Hospital n.a. V.A. Baranov
Petrozavodsk, 185019, Russia
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, 197022, Russia
Almazov National Medical Research Center
Saint Petersburg, 197341, Russia
Almazov National Medical Research Centre
Saint Petersburg, 197341, Russia
Samara State Medical University
Samara, 443099, Russia
Wits Baragwanath Clinical Hematology Department
Soweto, 1519, South Africa
City Hematology Center of Municipal Non-Profit Enterprise City Clinical Hospital #4 of Dnipro City Council
Dnipro, 49102, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2021
First Posted
May 7, 2021
Study Start
April 13, 2021
Primary Completion
May 1, 2024
Study Completion
October 1, 2025
Last Updated
May 9, 2022
Record last verified: 2022-05