ABBV-744 + Ruxolitinib/Navitoclax for Myelofibrosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for myelofibrosis (MF), a condition affecting bone marrow and blood cell production, leading to symptoms like severe anemia and an enlarged spleen. Researchers aim to determine the safe dose of ABBV-744 (an experimental treatment) and evaluate its effectiveness alone or with other drugs, such as ruxolitinib (a medication used to treat MF) or navitoclax. The trial consists of four parts, with some participants receiving ABBV-744 alone and others receiving it in combination with the other drugs. Suitable candidates have been diagnosed with MF and exhibit specific symptoms like a noticeably enlarged spleen or are currently taking ruxolitinib but still experience uncontrolled MF symptoms. Participants must attend regular hospital or clinic visits for monitoring and assessments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
For Segment A and C, you need to stop taking any Janus Kinase inhibitors at least 14 days before starting the trial. For Segment B, you must be on a stable dose of ruxolitinib for at least 14 days before starting, and you may need to reduce the dose if it's high. The protocol doesn't specify other medications, so it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In earlier studies, ABBV-744 alone showed limited effectiveness, but participants generally tolerated it well. Safety information indicates that side effects were manageable, though some patients experienced serious side effects at higher doses, highlighting the importance of finding the right dose. ABBV-744 is currently being tested with ruxolitinib, a drug used for myelofibrosis, which can cause side effects like low blood platelets and anemia. The goal of adding ABBV-744 is to enhance treatment without significantly increasing side effects.
ABBV-744 is also being tested with navitoclax, which targets cancer cells but can lead to low blood counts. The aim is to determine if ABBV-744 can improve treatment while keeping side effects manageable.
This is a Phase 1 trial, an early step in testing these combinations in people. Although there is less information on safety and tolerability compared to later stages, early testing shows that researchers are closely monitoring the treatments to find safe and effective doses.12345Why are researchers excited about this trial's treatments?
Unlike the standard of care for myelofibrosis, which often involves Janus Kinase inhibitors (JAK inhibitors) like ruxolitinib, ABBV-744 offers a new approach by targeting BET proteins. These proteins play a crucial role in regulating gene expression, which can influence cancer cell growth. ABBV-744 is unique because it can be paired with existing treatments like ruxolitinib and navitoclax to potentially enhance their effectiveness or serve as a standalone therapy. Researchers are excited about ABBV-744 because it might offer new hope for patients who haven't responded well to current therapies, providing a different mechanism to tackle the disease.
What evidence suggests that this trial's treatments could be effective for myelofibrosis?
In this trial, participants will receive different treatment combinations to evaluate their effectiveness for myelofibrosis. Research has shown that ABBV-744 alone is not very effective, with patients typically benefiting for only about 8.9 weeks. In this trial, some participants will receive ABBV-744 combined with ruxolitinib, and early results suggest improvements in spleen size and other symptoms, indicating a possible advantage. Another group will receive ABBV-744 with navitoclax, which has shown promise, with some patients experiencing improvements in bone marrow scarring. These early findings suggest that while ABBV-744 alone may not be very effective, combining it with ruxolitinib or navitoclax could offer more hope for people with myelofibrosis.12678
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ABBV-744 alone or in combination with ruxolitinib or navitoclax across four segments (A, B, C, D) until disease progression or intolerance
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ABBV-744
- Navitoclax
- Ruxolitinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois