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Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

ConditionsMyelofibrosisPost-PV MFPost-ET MyelofibrosisPrimary MyelofibrosisMF
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKartos Therapeutics, Inc.

About this trial

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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Navtemadlin

    Drug

    Navtemadlin is an investigational MDM2 inhibitor

  • Navtemadlin placebo

    Drug

    Navtemadlin placebo

  • Ruxolitinib

    Drug

    Ruxolitinib is a janus kinase 1/2 inhibitor

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 2 interventions
Group B: Arm 2Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

To compare spleen volume reduction (SVR35) between Arm 1 and Arm 2

The proportion of subjects in each arm with SVR35 by MRI/CT scan (central review) 24 weeks after start of the randomized period

Time frame
24 weeks
2

To compare total symptom score reduction (TSS50) between Arm 1 and Arm 2

The proportion of subjects in each arm with a TSS50 by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 24 weeks after start of the randomized period

Time frame
24 weeks

Secondary outcomes

1

To compare time to progression between Arm 1 and Arm 2

Time to progression or death from any cause in subjects randomized to each arm

Time frame
Up to 8 years
2

To compare overall survival (OS) between Arm 1 and Arm 2

Time to death from any cause in subjects randomized to each arm

Time frame
Up to 8 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kartos Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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