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Bcl-2 Inhibitor

Navitoclax + Ruxolitinib for Myelofibrosis (TRANSFORM-1 Trial)

Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has splenomegaly defined as spleen palpation measurement >= 5 centimeters (cm) below costal margin or spleen volume greater than or equal to 450 cubic cm as assessed centrally by magnetic resonance imaging (MRI) or computed tomography (CT) scan
Classified as intermediate-2, or high-Risk MF as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+)
Must not have
Prior treatment with a B-cell lymphoma 2 homology 3 (BH3)-mimetic compound or bromodomain and extra-terminal motif (BET) inhibitor or stem cell transplant
Prior treatment with a Janus Kinase-2 (JAK-2) inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 8 years
Awards & highlights
Pivotal Trial

Summary

This trial is investigating whether a combination of navitoclax and ruxolitinib is more effective and safe in assessment of change in spleen volume when compared to ruxolitinib in participants with myelofibrosis.

Who is the study for?
Adults with myelofibrosis, a bone marrow cancer causing anemia and enlarged spleen. Participants must have certain levels of disease severity and symptoms, be able to complete symptom assessments, and not be eligible for stem cell transplantation due to various reasons.
What is being tested?
The trial is testing if taking Navitoclax tablets along with Ruxolitinib is better than just Ruxolitinib for reducing spleen size in myelofibrosis patients. It's a global study involving around 230 participants who will receive treatments orally.
What are the potential side effects?
Potential side effects may include issues related to blood cells such as anemia or increased bleeding risk due to low platelets, fatigue from the treatment burden, and other possible drug-related reactions that will be monitored through regular medical checks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My spleen is enlarged, confirmed by a scan.
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My myelofibrosis is classified as intermediate-2 or high-risk.
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I have severe symptoms of my condition, scoring 3 or more on at least two.
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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 been diagnosed with Primary MyeloFibrosis or Secondary MyeloFibrosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously been treated with specific cancer drugs or had a stem cell transplant.
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I have been treated with a JAK-2 inhibitor before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 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
Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24)
Secondary study objectives
Change In Fatigue
Change in Physical Functioning
Change in Total Symptom Score (TSS)
+6 more

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: Navitoclax + RuxolitinibExperimental Treatment2 Interventions
Participants will receive Navitoclax in combination with Ruxolitinib
Group II: Placebo for Navitoclax + RuxolitinibActive Control2 Interventions
Participants will receive placebo for Navitoclax and Ruxolitinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Navitoclax
2012
Completed Phase 2
~120
Ruxolitinib
2018
Completed Phase 3
~1170

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,020 Previous Clinical Trials
519,839 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
442 Previous Clinical Trials
160,288 Total Patients Enrolled

Media Library

Navitoclax (Bcl-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04472598 — Phase 3
Myelofibrosis Research Study Groups: Navitoclax + Ruxolitinib, Placebo for Navitoclax + Ruxolitinib
Myelofibrosis Clinical Trial 2023: Navitoclax Highlights & Side Effects. Trial Name: NCT04472598 — Phase 3
Navitoclax (Bcl-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04472598 — Phase 3
~50 spots leftby Nov 2025
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