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RecruitingLast updated: 13 February 2026

POIESIS: This study is recruiting people with myelofibrosis to see if a combination of two targeted therapy drugs is more beneficial than oneA Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib Vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

POIESIS

Clinical summary

Summary

 

This clinical trial is looking at whether adding a medicine called navtemadlin to the standard treatment ruxolitinib can help people with myelofibrosis who aren't getting enough benefit from ruxolitinib on its own.

To start, everyone in the study will take ruxolitinib alone for a short period. If the treatment doesn't work well enough, the person will then be randomly assigned (by chance), to one of two treatment groups:

  • Ruxolitinib + Navtemadlin, or
  • Ruxolitinib + placebo.

The study is blinded, which means neither the participant nor the doctors will know whether the person is receiving navtemadlin or the placebo. 

Conditions

This trial is treating people with myelofibrosis

Eligibility

Inclusion

Inclusion Criteria for Ruxolitinib Alone Period:

  • Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by the treating physician according to the World Health Organization (WHO) criteria
  • High, Intermediate-1, Intermediate-2 risk category International Prognosis System Score (IPSS)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • JAK-inhibitor treatment naive

Inclusion Criteria for Randomized Period:

  • PMF, post-PV MF, or post-ET MF that is TP53WT as assessed by central testing
  • ECOG performance status of 0 to 2
  • Treatment with a stable dose of ruxolitinib
  • Suboptimal response to run-in ruxolitinib treatment

Exclusion

Exclusion Criteria for Ruxolitinib Alone Period:

  • Prior Splenectomy
  • Splenic irradiation within 3 months prior to the first dose
  • Prior BCL-XL, BET, MDM2, PI3K, PIM, or XPO1 inhibitors therapy or p53-directed therapy
  • Eligible for Bone Marrow Transplant
  • Peripheral blood or bone marrow blast count ≥ 10 percent

Exclusion Criteria for Randomized Period:

  • Elevated white blood cell count that doubles (or more) during ruxolitinib treatment and exceeds 50 × 10^9/L
  • Peripheral blood or bone marrow blast count ≥ 10 percent

Inclusion

  • You are able to swallow medication by mouth.
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Kartos Therapeutics, Inc.

Scientific Title

A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib Vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

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