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Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet Versus Best Available Therapy to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis
NCT04468984 · View on ClinicalTrials.gov ↗
Study Summary
Myelofibrosis (MF) is a rare blood cancer, notable for scarring of the bone marrow (the spongy tissue inside bones) and the spleen becoming larger. The purpose of this study is to assess safety and change in spleen volume when navitoclax is given in combination with ruxolitinib, compared to best available therapy, for adult participants with MF. Navitoclax is an investigational drug (not yet approved) being developed for the treatment of MF. Participants in this study will be randomly selected (like picking numbers out of a hat) to be in 1 of 2 treatment arms. Neither participants nor the study doctor will be able to pick which treatment arm a participants enters. In Arm A, participants will receive navitoclax in combination with ruxolitinib. In Arm B, participants will receive the best available therapy (BAT) for MF. In Arm C, participants will receive navitoclax. Adult participants with a diagnosis of MF that came back or did not get better after earlier treatment will be enrolled. Approximately 330 participants will be enrolled in approximately 322 sites across the world. In Arm A, participants will receive navitoclax tablet by mouth once daily with by mouth ruxolitinib tablet twice daily. In Arm B, participants will receive the BAT available to the investigator. In Arm C, participants will receive navitoclax tablet by mouth once daily. Participants will receive the study drug until they experience no benefit (determined by the investigator), participants cannot tolerate the study drugs, or participants withdraw consent. The approximate treatment duration is about 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.
Conditions Studied
Interventions
- DRUG Ruxolitinib
- DRUG Navitoclax
- DRUG Best Available Therapy (BAT)
Study Locations (20)
California
- City of Hope /ID# 218996 — Duarte
- Providence - St. Jude Medical Center /ID# 271382 — Fullerton
- Moores Cancer Center /ID# 271596 — La Jolla
- Moores Cancer Center at UC San Diego /ID# 219009 — La Jolla
- Long Beach Memorial Medical Ct /ID# 224542 — Long Beach
- Icri /Id# 221967 — Whittier
Illinois
- University of Chicago Medical Center /ID# 271373 — Chicago
- Northwest Oncology & Hematology - Elk Grove Village /ID# 222818 — Elk Grove Village
- Loyola University Medical Ctr /ID# 219048 — Maywood
Georgia
- Augusta University Georgia Cancer Center /ID# 219051 — Augusta
- Columbus Regional Research Institute /ID# 224410 — Columbus
Louisiana
- Tulane Medical Center - New Orleans /ID# 222940 — New Orleans
- Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 222777 — New Orleans
Arizona
- Ironwood Cancer & Res Ctr /ID# 222162 — Chandler
Arkansas
- Highlands Oncology Group, PA /ID# 221826 — Springdale
Colorado
- St. Mary's Hospital Regional Cancer Center /ID# 224229 — Grand Junction
Indiana
- Indiana Blood & Marrow Transpl /ID# 221587 — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2020-08-31 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04468984
The ClinicalTrials.gov registry entry for NCT04468984 describes a study currently listed as active not recruiting. 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 330 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: NCT04468984 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Illinois, Georgia. 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 NCT04468984 about?
NCT04468984 is a clinical study titled "Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet Versus Best Available Therapy to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis". Myelofibrosis (MF) is a rare blood cancer, notable for scarring of the bone marrow (the spongy tissue inside bones) and the spleen becoming larger. The purpose of this study is to assess safety and change in spleen volume when navitoclax is given in combination with ruxolitinib, compared to best ava...
What is the current status of trial NCT04468984?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2020-08-31. Estimated completion is 2026-12.
What conditions does trial NCT04468984 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 NCT04468984?
The interventions under investigation include: Ruxolitinib (DRUG), Navitoclax (DRUG), Best Available Therapy (BAT) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04468984?
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 NCT04468984 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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