Tests navtemadlin added to ruxolitinib in myelofibrosis patients with a weak response
Tests navtemadlin with ruxolitinib in adults with myelofibrosis responding poorly to ruxolitinib.
Key facts
- Who runs it
- Kartos Therapeutics, Inc.
- Where
- Amiens, Angers, Lille, Lyon, Nantes, Nice, Nîmes, Paris, Pessac, Poitiers, Strasbourg, Toulouse, and Tours, FranceSee the 14 sitesAlso in 18 other countries, 201 sites
- Trial code
- Registry title
- Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 600 people, planned
- Started
- 3 Jun 2024
- Expected to end
- 31 Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Navtemadlin
- Navtemadlin placebo
- Ruxolitinib
- Record updated
- 25 September 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with myelofibrosis who have not had a JAK inhibitor before. Everyone first takes ruxolitinib. Those with a weak response then get navtemadlin or placebo added.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Primary myelofibrosis, post-PV MF or post-ET MF. IPSS risk category High, Intermediate-1 or Intermediate-2. ECOG performance status 0 to 2.
- Earlier treatment
- Must not have had a JAK inhibitor before. Must have a weak response to the first ruxolitinib period and be on a stable ruxolitinib dose to be randomized.
- Biomarker or test result
- TP53 wild-type, shown by central testing, to be randomized.
Main reasons for not taking part
- Prior splenectomy
- Splenic irradiation within 3 months before the first dose
- Prior BCL-XL, BET, MDM2, PI3K, PIM or XPO1 inhibitor therapy or p53-directed therapy
- Able to have a bone marrow transplant
- Blast count of 10 percent or more in blood or bone marrow
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
- 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
Who cannot take part
- 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
- 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 in France
Also in 18 other countries, 201 sites
- Amiens Picardie University Hospital - SouthAmiens, FranceContact: John MeiTaking people
- Angers University Hospital CenterAngers, FranceContact: John MeiTaking people
- Lille Regional University Hospital CenterLille, FranceContact: John MeiTaking people
- Leon Berard CenterLyon, FranceContact: John MeiTaking people
- South Lyon Hospital CenterLyon, FranceContact: John MeiTaking people
- Nantes University Hospital Center - Hotel Dieu HospitalNantes, FranceContact: John MeiTaking people
- Archet 1 and 2 hospitalNice, FranceContact: John MeiTaking people
- Nimes University Hospital Center, Department of Clinical Hematology and Medical OncologyNîmes, FranceContact: John MeiTaking people
- Saint-Louis Hospital, Department of Adult HematologyParis, FranceContact: John MeiTaking people
- Bordeaux University HospitalPessac, FranceContact: John MeiTaking people
- University Hospital Center of PoitiersPoitiers, FranceContact: John MeiTaking people
- Strasbourg Europe Institut of CancerologyStrasbourg, FranceContact: John MeiTaking people
- University Hospital of Toulouse, IUCT-OncopoleToulouse, FranceContact: John MeiTaking people
- Tours Regional University Hospital CenterTours, FranceContact: John MeiTaking people
About the trial
What the trial wants to find out
This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone.
Read full original descriptionShow less
Subjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.
The 2 groups in the trial
- Arm 1Treatment being tested
Navtemadlin administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day.
Treatment: Navtemadlin and Ruxolitinib
- Arm 2Existing treatment, for comparison
Navtemadlin placebo administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day.
Treatment: Navtemadlin placebo and Ruxolitinib
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official 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
- Plain-language title
- Tests navtemadlin added to ruxolitinib in myelofibrosis patients with a weak responseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 25 September 2025