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Bcl-2 inhibitor

Navitoclax + Ruxolitinib for Myelofibrosis (REFINE Trial)

Phase 2

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Participants with documented diagnosis of intermediate-2 or high-risk primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis

Eastern Cooperative Oncology Group (ECOG) of 0, 1, or 2

Must not have

Participant is currently on medications that interfere with coagulation (including warfarin) or platelet function within 3 days prior to the first dose of study drug or during the study treatment period with the exception of low dose aspirin (up to 100 mg/day) and low-molecular-weight heparin

Prior therapy with a BH3 mimetic compound or stem cell transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 12 weeks up to approximately 96 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug to treat myelofibrosis, a bone marrow disease. The drug will be given alone or with another drug, to see if it is effective and has few side effects.

Who is the study for?

This trial is for people with myelofibrosis who've been treated with a JAK-2 inhibitor for at least 12 weeks and have significant symptoms or are considered intermediate-2/high-risk. They should be on a stable dose of ruxolitinib if currently taking it, not have had certain prior treatments, and must meet specific health criteria.

What is being tested?

The study tests the safety and effectiveness of Navitoclax alone or combined with Ruxolitinib in treating myelofibrosis. It's an open-label Phase 2 trial, meaning both researchers and participants know which treatment is being administered.

What are the potential side effects?

Potential side effects may include issues affecting blood cells like anemia (low red blood cell count) or thrombocytopenia (low platelet count), digestive disturbances, fatigue, and possibly increased risk of bleeding due to interference with normal clotting.

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 high-risk form of Myelofibrosis.

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

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I have severe symptoms of myelofibrosis, scoring high on the symptom assessment.

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My spleen is enlarged.

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My blood, kidney, and liver tests meet the required levels.

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I have been treated with ruxolitinib before.

Exclusion Criteria

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

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I am not on blood thinners, except for low dose aspirin or low-molecular-weight heparin.

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I have previously received treatment with a BH3 mimetic or had a stem cell transplant.

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I have had my spleen removed or received spleen radiation in the last 6 months.

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My blood or bone marrow has more than 10% cancer cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 12 weeks up to approximately 96 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 12 weeks up to approximately 96 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 weeks up to approximately 96 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Participants who achieve Spleen Volume Reduction of greater than or equal to 35% (SVR35) from baseline

Secondary study objectives

Anemia

Change in Grade of Bone Marrow Fibrosis

Percentage of participants achieving 50% Reduction in Total System Score (TSS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Navitoclax + ruxolitinibExperimental Treatment2 Interventions

Participants will be administered navitoclax once daily (QD) at various doses and a dose greater than or equal to 10 mg of ruxolitinib twice daily (BID).

Group II: NavitoclaxExperimental Treatment1 Intervention

Participants will be administered various doses of navitoclax once daily (QD)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib

2018

Completed Phase 3

~1170

Navitoclax

2012