BridgeMD
KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment (BOREAS)
EU CTIS ID: 2024-513912-89-00
What this study is testing
Part A: To determine spleen response. Part B: To compare the spleen volume reduction (SVR) at Week 24 between Arm 1 and Arm 2.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Part A: Adults ≥18 years of age
- Part B: Failure of prior treatment with JAK inhibitor
- Part B: ECOG ≤ 2
- Part A: Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
- Part A: High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)
- Part A: Failure of prior treatment with JAK inhibitor
You likely can't join if
- Part A: Subjects who are positive for P53 mutations
- Part A: Grade 2 or higher QTc prolongation (> 480 milliseconds per NCI-CTCAE criteria, version 5.0)
- Part B: Prior splenectomy
- Part B: Splenic irradiation within 12 weeks of randomization
- Part B: Prior allogeneic stem-cell transplantation or plans for allogeneic stem cell transplantation
- Part B: Prior MDM2 inhibitor therapy or p53-directed therapy
See the full eligibility criteria
- Part A: Adults ≥18 years of age
- Part B: Failure of prior treatment with JAK inhibitor
- Part B: ECOG ≤ 2
- Part A: Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
- Part A: High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)
- Part A: Failure of prior treatment with JAK inhibitor
- Part A: ECOG ≤ 2
- Part B: Adults >18 years of age
- Part B: Confirmed diagnosis of PMF, post PV-MF, or post-ET-MF (WHO)
- Part B: High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)
- Part B: Subjects with p53WT MF by central laboratory testing
- Part A: Subjects who are positive for P53 mutations
- Part A: Grade 2 or higher QTc prolongation (> 480 milliseconds per NCI-CTCAE criteria, version 5.0)
- Part B: Prior splenectomy
- Part B: Splenic irradiation within 12 weeks of randomization
- Part B: Prior allogeneic stem-cell transplantation or plans for allogeneic stem cell transplantation
- Part B: Prior MDM2 inhibitor therapy or p53-directed therapy
- Part B: JAK-, PI3k-, SYK-, BTK-, BET- or MTOR inhibitor treatment within 28 days prior to the Screening MRI/CT scan
- Part A: Prior splenectomy
- Part B: History of major hemorrhage or intracranial hemorrhage within 6 months prior to randomization
- Part B: History of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to randomization
- Part A: Splenic irradiation within 3 months prior to randomization
- Part A: History of major hemorrhage or intracranial hemorrhage within 6 months prior to randomization
- Part A: History of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to randomization
- Part A: Prior MDM2 inhibitor therapy or p53-directed therapy
- Part A: Prior allogeneic stem-cell transplant or plans for allogeneic stem cell transplant
- Part B: History of major organ transplant
- Part B: Grade 2 or higher QTc prolongation (>480 milliseconds per NCI- CTCAE criteria, version 5.0)
- Part A: History of major organ transplant
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- Russian Federation
- Turkey
- Philippines
- Thailand
- Australia
- Brazil
- Mexico
- United States
- Argentina
- Hong Kong
- United Kingdom
- Israel
- Canada
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; Russian Federation; Turkey; Philippines; Thailand; Australia and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.