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Navitoclax + Ruxolitinib for Myelofibrosis (TRANSFORM-2 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
Appearance of new splenomegaly that is palpable to at least 5 cm below the left costal margin (LCM) in participants with no evidence of splenomegaly prior to the initiation of ruxolitinib.
Classified as intermediate-2 or high-risk MF, as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+).
Must not have
Received prior treatment with a BH3-mimetic compound, bromodomain and extra-terminal (BET) inhibitor, or prior use of > 1 JAK2 inhibitor or stem cell transplant.
Receiving medication that interferes with coagulation or platelet function within 3 days prior to the first dose of study drug or during the study treatment period except for low dose aspirin (up to 100 mg daily) and low molecular weight heparin (LMWH).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up last visit up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is investigating whether the combination of navitoclax and ruxolitinib is safe and effective in participants with myelofibrosis. Participants will be assigned to either Arm A or Arm B. Arm A will receive navitoclax and ruxolitinib, while Arm B will receive the best available therapy.

Who is the study for?
Adults with relapsed or refractory Myelofibrosis, a type of blood cancer that causes bone marrow scarring and spleen enlargement. Participants must have specific symptoms and spleen size criteria, be classified as intermediate-2 or high-risk by DIPSS+, and have been treated with ruxolitinib previously but not responded well.
What is being tested?
The trial is testing the safety and effectiveness of an oral Navitoclax tablet in combination with Ruxolitinib versus Best Available Therapy (BAT) for reducing spleen volume in Myelofibrosis patients. It's a randomized study where neither participants nor doctors choose the treatment group.
What are the potential side effects?
Potential side effects may include digestive issues, changes in blood counts, fatigue, potential risk of infection due to immune system impact, liver function changes, bleeding complications, and other drug-specific reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My spleen has grown and can be felt at least 5 cm below my left rib cage since starting ruxolitinib.
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My myelofibrosis is classified as intermediate-2 or high-risk.
Select...
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 a type of myelofibrosis according to WHO, with significant bone marrow scarring.
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I've been on ruxolitinib for less than 6 months and my disease has worsened.
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I have symptoms scoring 3 or more on average, or a total score of 12 or more on the MFSAF v4.0.
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My spleen has grown significantly since starting my current treatment.
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My spleen has grown by 25% or more since starting ruxolitinib.
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My spleen is enlarged, measuring over 5 cm below my ribcage or has a volume of more than 450 cm3 on a scan.
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I have been treated with ruxolitinib for my condition.
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My spleen has grown significantly since starting my treatment.
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I took ruxolitinib for 6 months or more but stopped because it didn't reduce my spleen size or symptoms got worse after initially improving.
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I've taken ruxolitinib (at least 10 mg twice daily) for over 28 days but had to stop because I needed more blood transfusions.
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I can tolerate ruxolitinib doses of 10 mg or more without severe side effects.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have previously been treated with specific cancer drugs or had a stem cell transplant.
Select...
I am not on blood thinners, except for low dose aspirin or LMWH.
Select...
I am eligible for a stem cell transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~last visit up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and last visit up to 5 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
Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at any time
Percentage of Participants who achieve at least 50% Reduction in Total Symptom Score (TSS)
Anemia
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 A: Navitoclax + RuxolitinibExperimental Treatment2 Interventions
Participants will receive navitoclax tablets once daily and ruxolitinib tablets twice daily.
Group II: Arm B: Best Available Therapy (BAT)Active Control1 Intervention
Participants will receive one of the BAT options, per the investigator's discretion.
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
1,023 Previous Clinical Trials
519,994 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
444 Previous Clinical Trials
160,480 Total Patients Enrolled

Media Library

Best Available Therapy (BAT) Clinical Trial Eligibility Overview. Trial Name: NCT04468984 — Phase 3
Myelofibrosis Research Study Groups: Arm B: Best Available Therapy (BAT), Arm A: Navitoclax + Ruxolitinib
Myelofibrosis Clinical Trial 2023: Best Available Therapy (BAT) Highlights & Side Effects. Trial Name: NCT04468984 — Phase 3
Best Available Therapy (BAT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04468984 — Phase 3
~11 spots leftby Jan 2025
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