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NCT06479135RECRUITINGIRB Ready

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

(POIESIS)

Sponsored by Kartos Therapeutics, Inc.

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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

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 β‰₯ 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 Criter

❓ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

600 participants

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Gender

ALL

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Sponsor

Kartos Therapeutics, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Birmingham

Alabama

Location available
View Birmingham location page
RECRUITING

Gilbert

Arizona

Location available
View Gilbert location page
RECRUITING

Phoenix

Arizona

Location available
View Phoenix location page
RECRUITING

La Jolla

California

Location available
View La Jolla location page
RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
RECRUITING

San Diego

California

Location available
View San Diego location page
RECRUITING

Torrance

California

Location available
View Torrance location page
RECRUITING

Aurora

Colorado

Location available
View Aurora location page
RECRUITING

Newark

Delaware

Location available
View Newark location page

πŸ“ And 49 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

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Looking for Myelofibrosis Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

Myelofibrosis Treatment Options in Birmingham, Alabama

If you're searching for Myelofibrosis treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, Gilbert, Phoenix and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Myelofibrosis. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 600 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Myelofibrosis?

Potential Benefits

  • βœ“Access to new treatment approaches before public availability
  • βœ“Close monitoring by experienced medical professionals
  • βœ“Study-related care provided at no cost
  • βœ“Contribute to medical research for Myelofibrosis

What to Expect

  • β†’Initial screening to determine eligibility
  • β†’Regular check-ups and monitoring visits
  • β†’Possible compensation for time and travel
  • β†’You can withdraw at any time

Frequently Asked Questions About This Myelofibrosis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06479135. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.