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ABBV-744 + Ruxolitinib/Navitoclax for Myelofibrosis

Phase 1

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Documented diagnosis of intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera MF (PPV-MF) or post-essential thrombocytopenia MF (PET-MF) as defined by the World Health Organization (WHO).

Currently receiving ruxolitinib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 1 year from start of study

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and tolerability of ABBV-744 in adult participants with myelofibrosis. ABBV-744 will be given alone and in combination with either ruxolitinib or navitoclax.

Who is the study for?

Adults with Myelofibrosis (MF), a bone marrow disorder, can join this trial. They must have tried a JAK inhibitor treatment before and either didn't respond well or it stopped working. Their spleen should be enlarged, they need to be in decent physical shape (ECOG <=2), and their organs must function adequately as per specific lab values.

What is being tested?

The study tests ABBV-744's safety alone or combined with ruxolitinib/navitoclax in treating MF. It has four parts: finding the safe dose of ABBV-744; then testing it with ruxolitinib ('add-on' therapy); combining it with navitoclax; and another combination regimen with ruxolitinib.

What are the potential side effects?

Potential side effects include typical drug reactions like nausea, fatigue, liver issues, kidney problems, blood cell count changes leading to increased infection risk or bleeding tendencies. The burden of treatment might be higher than standard care.

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 serious form of myelofibrosis.

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I am currently taking ruxolitinib.

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I am able to care for myself and perform daily activities.

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I have been on ruxolitinib for 24 weeks or more, but it's not working for my condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 1 year from start of study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 1 year from start of study

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 year from start of study 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 With Adverse Events

Secondary study objectives

Accumulation Ratio Of ABBV-744

Apparent Clearance (CL/F) Of ABBV-744

Apparent Volume Of Distribution (Vd/F) Of ABBV-744

+13 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: Segment D: ABBV-744 + RuxolitinibExperimental Treatment2 Interventions

Participants who have never received JAKi will receive ABBV-744 and ruxolitinib.

Group II: Segment C: ABBV-744 + NavitoclaxExperimental Treatment2 Interventions

Participants who have previously been exposed to JAKi, and stopped such therapy, will receive ABBV-744 and navitoclax.

Group III: Segment B: Ruxolitinib + ABBV-744 "Add on" TherapyExperimental Treatment2 Interventions

Participants whose disease (myelofibrosis) is inadequately controlled by ongoing ruxolitinib therapy will receive ruxolitinib and ABBV-744 as "add-on" therapy.

Group IV: Segment A: ABBV-744 MonotherapyExperimental Treatment1 Intervention

Participants will receive the identified safe dosing regimen of ABBV-744 as monotherapy.

Group V: Segment A: ABBV-744 Dose Identification and OptimizationExperimental Treatment1 Intervention

Participants who have been previously treated with Janus Kinase inhibitor(s) (JAKi) and stopped such therapy, will receive different dosing regimens and schedules of ABBV-744 to identify the safe dosing regimen and schedule.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Navitoclax

2015

Completed Phase 2

~150

Ruxolitinib

2018

Completed Phase 3

~1170