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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
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 belowSelect...
I have been diagnosed with a serious form of myelofibrosis.
Select...
I am currently taking ruxolitinib.
Select...
I am able to care for myself and perform daily activities.
Select...
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
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 moreTrial 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
2012
Completed Phase 2
~120
Ruxolitinib
2018
Completed Phase 3
~1140
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,004 Previous Clinical Trials
513,757 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
430 Previous Clinical Trials
156,077 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My spleen is enlarged, confirmed by a scan.My condition is considered intermediate-2 or high-risk, or I have a significantly enlarged spleen.I have been diagnosed with a serious form of myelofibrosis.My blood, kidney, and liver tests meet the required levels.I've completed the MFSAF with at least 2 symptoms scoring 3 or more, or a total score of 10 or more.I am currently taking ruxolitinib.I am able to care for myself and perform daily activities.I have been on ruxolitinib for 24 weeks or more, but it's not working for my condition.I have tried a JAK inhibitor for my condition but stopped it more than 14 days ago due to no improvement or side effects.I am willing to lower my ruxolitinib dose if it's high and have been on a stable dose for at least 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Segment A: ABBV-744 Dose Identification and Optimization
- Group 2: Segment D: ABBV-744 + Ruxolitinib
- Group 3: Segment B: Ruxolitinib + ABBV-744 "Add on" Therapy
- Group 4: Segment A: ABBV-744 Monotherapy
- Group 5: Segment C: ABBV-744 + Navitoclax
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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