Adding navtemadlin to ruxolitinib for myelofibrosis patients with poor response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of adding navtemadlin to ruxolitinib treatment for patients with myelofibrosis who have not responded adequately to ruxolitinib alone. Initially, participants will receive ruxolitinib during a run-in period, and those showing a suboptimal response will be randomly assigned to receive either navtemadlin or a placebo alongside their ongoing ruxolitinib treatment. The study is designed to be blinded, ensuring that neither the participants nor the healthcare providers know which treatment is being administered. This approach aims to determine if the combination therapy can provide better clinical outcomes than ruxolitinib alone.

Why it matters

Who can join: the full rules

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

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

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 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

Where it's running

• UAB Hospital
  Birmingham, Alabama, United States Recruiting
• Banner MD Anderson Cancer Center
  Gilbert, Arizona, United States Recruiting
• Mayo Clinic - Phoenix
  Phoenix, Arizona, United States Recruiting
• UC San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• UCLA Hematology/Oncology Clinic - Los Angeles
  Los Angeles, California, United States Recruiting
• Scripps Health, Prebys Cancer Center
  San Diego, California, United States Recruiting

+165 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: John Mei
• Email: jmei@kartosthera.com
• Phone: 650-542-0136

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining TL-895 with Ruxolitinib for treating Myelofibrosis

  This study is testing if combining TL-895 with Ruxolitinib can help people with Myelofibrosis feel better, especially those who haven't responded well to Ruxolitinib alone.

  Recruiting at 19 sites Phase 1/2 Telios Pharma, Inc. · Birmingham, Alabama and 18 other locations · NCT05280509

• MPN PROGRESSion Registry — tracking symptoms, treatments, and disease progression in people with MPNs.

  Track long-term symptoms, treatments, and disease progression in adults with myeloproliferative neoplasms to see how these conditions evolve over time.

  Recruiting at 2 sites MPN Research Foundation · Chicago, Illinois and 1 other locations · NCT07362225

• National registry for people with myelofibrosis and anemia in Germany.

  This project will collect health, treatment, and quality-of-life information from people in Germany with primary or secondary myelofibrosis and anemia to see how their care and symptoms change over time.

  Recruiting iOMEDICO AG · Multiple Locations · NCT06976918

• Combining Momelotinib and Luspatercept for Myelofibrosis Treatment

  This study is testing if combining two medications, momelotinib and luspatercept, can help people with myelofibrosis who need blood transfusions feel better and reduce their transfusion needs.

  Recruiting at 33 sites Phase 2 GlaxoSmithKline · Ann Arbor, Michigan and 32 other locations · NCT06517875

• Observational study on ruxolitinib for myelofibrosis patients

  This study looks at how well ruxolitinib works for people with myelofibrosis and how different factors affect their long-term survival.

  Recruiting at 26 sites IRCCS Azienda Ospedaliero-Universitaria di Bologna · Cosenza, Calabria and 25 other locations · NCT06516406

• Evaluating DISC-0974 for treating anemia in myelofibrosis patients

  This study tests if a new treatment called DISC-0974 can help people with myelofibrosis who have anemia feel better and improve their condition.

  Recruiting at 33 sites Phase 1/2 Disc Medicine, Inc · Gilbert, Arizona and 34 other locations · NCT05320198

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.