Status:
UNKNOWN
Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
Lead Sponsor:
Kartos Therapeutics, Inc.
Conditions:
Primary Myelofibrosis (PMF)
Post-Polycythemia Vera Myelofibrosis (Post-PV-MF)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04878003
Start Date
April 13 2021
End Date
October 1 2025
Last Update
May 9 2022
Active Locations (29)
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1
Innovative Clinical Research Institute
Glendale, California, United States, 90603
2
Innovative Clinical Research Institute
Whittier, California, United States, 90603
3
Gabrail Cancer Center
Canton, Ohio, United States, 44718
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030