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Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis
NCT04472598 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Ruxolitinib
- DRUG Navitoclax
- DRUG Placebo for Navitoclax
Study Locations (20)
Florida
- Lynn Cancer Institute, Boca /ID# 230687 — Boca Raton
- Florida Cancer Specialist - South /ID# 221726 — Fort Myers
- Florida Cancer Specialists - North /ID# 221727 — St. Petersburg
- Florida Cancer Specialists - East /ID# 221728 — West Palm Beach
Georgia
- Duplicate_Emory University /ID# 221562 — Atlanta
- Augusta University Georgia Cancer Center /ID# 221551 — Augusta
- Columbus Regional Research Institute /ID# 227272 — Columbus
Massachusetts
- Massachusetts General Hospital /ID# 221559 — Boston
- Beth Israel Deaconess Medical Center /ID# 224261 — Boston
- Dana-Farber Cancer Institute /ID# 218010 — Boston
California
- Providence - St. Jude Medical Center /ID# 241646 — Fullerton
- Moores Cancer Center at UC San Diego /ID# 218012 — La Jolla
Illinois
- Duplicate_Rush University Medical Center /ID# 221581 — Chicago
- Mid Illinois Hematology & Oncology Associates, Ltd /ID# 224204 — Normal
Arkansas
- Highlands Oncology Group, PA /ID# 221824 — Springdale
Colorado
- Rocky Mountain Cancer Centers - Littleton /ID# 222562 — Littleton
Indiana
- Indiana Blood & Marrow Transpl /ID# 221586 — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2020-09-29 |
| Est. Completion | 2025-01-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04472598
The ClinicalTrials.gov registry entry for NCT04472598 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 252 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Myelofibrosis (MF) appearing as the primary indexed condition, and to 3 interventions — of which Ruxolitinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04472598 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Georgia, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04472598 about?
NCT04472598 is a clinical study titled "Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis". 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, whic...
What is the current status of trial NCT04472598?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 252 participants. The study started on 2020-09-29. Estimated completion is 2025-01-29.
What conditions does trial NCT04472598 study?
This clinical trial studies the following conditions: Myelofibrosis (MF). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04472598?
The interventions under investigation include: Ruxolitinib (DRUG), Navitoclax (DRUG), Placebo for Navitoclax (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04472598?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04472598 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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