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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Adverse Events
Secondary outcome measures
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
~90
Ruxolitinib
2018
Completed Phase 3
~1140
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
954 Previous Clinical Trials
501,084 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,918 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the efficacy of ABBV-744 been investigated through other medical experiments?
"Since 2002, ABBV-744 has been studied extensively at the National Institutes of Health Clinical Center. 111 studies have already concluded and 103 are still recruiting subjects from locations such as Dallas and Washington D.C."
Answered by AI
How many hospitals in North America are involved with this clinical research?
"This particular trial is recruiting patients in 12 cities, such as Dallas, Seattle and Worcester. To best minimize travel commitments associated with this study, it is recommended to join the nearest site available to you."
Answered by AI
What afflictions is ABBV-744 designed to alleviate?
"ABBV-744 is frequently used to manage polycythemia vera. Additionally, it can be prescribed for various other illnesses such as hydroxyurea intolerance/resistance and primary myelofibrosis."
Answered by AI
How many individuals are partaking in this medical experiment?
"AbbVie, the trial sponsor, is recruiting 130 eligible patients from different sites including Texas Oncology- Baylor Charles A. Sammons Cancer Center/ID# 240004 in Dallas and Washington VA Puget Sound Health Care System /ID# 224208 in Seattle to complete this study."
Answered by AI
Are participants still being selected for this experiment?
"Affirmative, according to information on clinicaltrials.gov the trial is currently open for enrollment. This study was originally posted on November 11th 2020 and was last modified on October 20th 2022. 130 participants are needed across 12 sites."
Answered by AI
What is the current regulatory status of ABBV-744?
"There is minimal clinical data currently available for ABBV-744, thus our team at Power assign it a safety rating of 1."
Answered by AI
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