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JAK Inhibitor

Navtemadlin + Ruxolitinib for Myelofibrosis (POIESIS Trial)

Phase 3

Recruiting

Research Sponsored by Kartos Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of PMF, post-PV MF, or post-ET MF according to WHO criteria

JAK-inhibitor treatment naive

Must not have

Prior Splenectomy

Splenic irradiation within 3 months prior to the first dose

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 years

Awards & highlights

Pivotal Trial

Summary

"This trial is testing if adding navtemadlin to ruxolitinib treatment will be more helpful than using ruxolitinib alone for patients with Myelofibrosis who don't

Who is the study for?

This trial is for patients with Myelofibrosis who haven't had a good enough response to Ruxolitinib. Participants should be new to JAK inhibitor treatments and meet specific health criteria not detailed here.

What is being tested?

The study tests if adding Navtemadlin to Ruxolitinib offers more benefits than Ruxolitinib alone in Myelofibrosis patients with poor responses. It's randomized and blinded, meaning treatment assignments are by chance and unknown to participants and researchers.

What are the potential side effects?

Possible side effects of Navtemadlin may include gastrointestinal symptoms, fatigue, liver issues, or muscle-related problems. Side effects from Ruxolitinib can range from anemia and low blood platelets to dizziness and headache.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a form of myelofibrosis according to WHO standards.

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I have never been treated with JAK inhibitors.

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My myelofibrosis is TP53 wild-type.

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I am currently on a stable dose of ruxolitinib.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had my spleen removed.

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I have not had splenic irradiation in the last 3 months.

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I have previously received treatments targeting specific cancer pathways or p53.

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I am eligible for a bone marrow transplant.

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My white blood cell count more than doubled and exceeded 50 × 10^9/L during ruxolitinib treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

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

To compare time to progression between Arm 1 and Arm 2

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1Experimental Treatment2 Interventions

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.

Group II: Arm 2Active Control2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib

2018

Completed Phase 3

~1170

0 / 10Eligibility criteria met