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Bcl-2 inhibitor

Navitoclax + Ruxolitinib for Myelofibrosis (REFINE Trial)

Q: What medical treatments does Navitoclax regularly facilitate?

<p>Patients suffering from <a href="https://www.withpower.com/clinical-trials/polycythemia-vera">polycythemia vera</a>, polycythemia, or those who are resistant to hydroxyurea may be able to gain relief through Navitoclax medication.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 12 weeks up to approximately 96 weeks

Awards & highlights

REFINE Trial 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.Check my eligibility

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.See study design

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.

REFINE Trial 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.

REFINE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Anemia

Change in Grade of Bone Marrow Fibrosis

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

REFINE 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

~1140

Navitoclax

2012

Completed Phase 2

~90

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

500,914 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

394 Previous Clinical Trials

145,748 Total Patients Enrolled

Media Library

Navitoclax (Bcl-2 inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03222609 — Phase 2

Myelofibrosis Research Study Groups: Navitoclax + ruxolitinib, Navitoclax

Myelofibrosis Clinical Trial 2023: Navitoclax Highlights & Side Effects. Trial Name: NCT03222609 — Phase 2

Navitoclax (Bcl-2 inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03222609 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical treatments does Navitoclax regularly facilitate?

"Patients suffering from polycythemia vera, polycythemia, or those who are resistant to hydroxyurea may be able to gain relief through Navitoclax medication."

Answered by AI

Are recruitment opportunities for this trial still being offered?

"As displayed on clinicaltrials.gov, this medical trial has ceased recruitment of patients at present. It was initially posted on October 31st 2017 and underwent its most recent update on September 9th 2022. Nevertheless, there are still 212 other trials requiring participants across the world today."

Answered by AI

In what locations is this research experiment being conducted?

"This trial is being conducted in 71 places, including West Penn Hospital (ID# 222618) of Pittsburgh, Pennsylvania; University Cancer & Blood Centre (ID# 230939) situated in Athens, Georgia; and Jewish General Hospital (ID# 217586), located in Montreal, Quebec."

Answered by AI

What other research endeavors have included Navitoclax as a component?

"In 2002, the National Institutes of Health Clinical Center located at 9000 Rockville Pike launched a study into Navitoclax. Since then 111 trials have been completed and 103 are currently active, many situated in Pittsburgh, Pennsylvania."

Answered by AI

What is the aggregate count of participants in this experiment?

"Sadly, this investigation has ceased to accept new participants. It was initially published on October 31st 2017 and last updated September 9th 2022. If you're seeking other clinical trials, there are 109 studies currently recruiting patients with primary myelofibrosis and 103 involving Navitoclax that need volunteers."

Answered by AI