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NCT04472598 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Myelofibrosis (MF), sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 252
- Enrollment target
- 20
- Study locations
NCT04472598: Completed Phase 3 study of Myelofibrosis (MF), sponsored by AbbVie.
NCT04472598 is a Phase 3 study of Myelofibrosis (MF) that has completed, run by AbbVie. The registered enrollment target is 252 participants, below the 944-participant average among 6 other Myelofibrosis (MF) trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04472598, a Phase 3 study of Myelofibrosis (MF), has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 252 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Reduction in spleen volume is measured by magnetic resonance imaging (MRI) or computed tomography (CT), per International Working Group (IWG) criteria.
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 |
What the finished NCT04472598 record still lists
NCT04472598 is an interventional study that assigns participants to a tested intervention. The registered 252 participants enrollment target is mid-sized for trials with a published cap, below the 944-participant average among 6 other Myelofibrosis (MF) trials with a reported enrollment target (73% lower).
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.
NCT04472598 names 20 study sites across 11 states, led by Florida, Georgia, Massachusetts.
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).
What interventions are being tested in trial NCT04472598?
The interventions under investigation include: Ruxolitinib (DRUG), Navitoclax (DRUG), Placebo for Navitoclax (DRUG).
Who is sponsoring clinical trial NCT04472598?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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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