Drug Pipeline
PHASE3
● Phase III
Phase 3 trial of navitoclax plus ruxolitinib versus ruxolitinib alone in myelofibrosis posts results
ClinicalTrials.gov
Published March 30, 2026
AbbVie
NCT04472598 ↗
A phase 3 randomized controlled trial was conducted at approximately 190 sites worldwide, enrolling 252 adult participants with a diagnosis of myelofibrosis. The study compared the combination of oral navitoclax plus oral ruxolitinib against oral ruxolitinib plus an oral placebo. The primary efficacy endpoint was the percentage of participants achieving at least a 35% reduction from baseline in spleen volume at week 24 (SVR35W24). The follow-up duration was 30.4 months. No efficacy results, including the primary outcome, secondary outcomes, effect sizes, or p-values, are reported in the available data. Safety and tolerability data, including adverse events, serious adverse events, and discontinuation rates, are also not reported. The lead sponsor was AbbVie. A key limitation is that the results posted date is listed as March 23, 2026, which is in the future relative to the context of the source text, indicating the clinical trial results are not yet available for analysis. Therefore, no conclusions regarding efficacy, safety, or practice relevance can be drawn from this structured data at this time.
Imagine carrying around a constant, painful pressure in your side that makes it hard to eat or move comfortably. That's the reality for many people with myelofibrosis, a rare bone marrow cancer that often causes the spleen to swell dramatically. A major new study aimed to see if a two-drug attack could bring relief.
The trial enrolled 252 adults with myelofibrosis at nearly 190 clinics worldwide. All participants received the standard drug, ruxolitinib. Half also got an experimental pill called navitoclax, while the other half got a placebo. The main goal was to see if the combination could shrink spleen volume by at least 35% after 24 weeks.
Here's the crucial part: the results are not yet available. The study is complete, with participants followed for over two years, but the findings on whether the combination worked and how safe it was haven't been released. The drug navitoclax is still under investigation.
This means we simply don't know yet if adding this new drug helps patients feel better or live longer. The sponsor, AbbVie, has posted that results will be available in 2026, so for now, patients and doctors are waiting for the full picture from this important Phase 3 trial.
What this means for you: Results from a major myelofibrosis combination drug trial are pending; safety and effectiveness are not yet known.
View Original Abstract ↓
Status: COMPLETED | Phase: PHASE3
Condition(s): Myelofibrosis (MF)
Intervention(s): Placebo for Navitoclax (DRUG), Ruxolitinib (DRUG), Navitoclax (DRUG)
Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts body's normal production of blood cells. It causes bone marrow scarring, leading to severe anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an enlarged spleen. The purpose of this study is to see if a combination of navitoclax and ruxolitinib is more effective and safe in assessment of change in spleen volume when compared to ruxolitinib in participants with myelofibrosis.
Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in this study are divided into two groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled. Around 230 participants will be enrolled in approximately 190 sites worldwide.
Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue untill the participant cannot tolerate the study drug, or benefit is not achieved, or other reasons which qualify for discontinuation of the study drug.
There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, magnetic resonance imaging (MRI) or computed tomography (CT) scan, bone marrow tests, checking for side effects, and completing questionnaires.
Primary Outcome(s): Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume at Week 24 (SVR35W24)
Enrollment: 252 (ACTUAL)
Lead Sponsor: AbbVie
Start: 2020-09-29 | Primary Completion: 2023-04-13
Results posted: 2026-03-23
