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NCT04401748 · ClinicalTrials.gov registry record · Phase 3
Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome
A Phase 3 study of Myelodysplastic Syndrome (MDS), sponsored by AbbVie.
- Active
- Registry status
- Phase 3
- Development phase
- 531
- Enrollment target
- 20
- Study locations
NCT04401748: Active Phase 3 study of Myelodysplastic Syndrome (MDS), sponsored by AbbVie.
NCT04401748 is a Phase 3 study of Myelodysplastic Syndrome (MDS) that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 531 participants, above the 58-participant average among 19 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (816% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04401748, a Phase 3 study of Myelodysplastic Syndrome (MDS), is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 531 participants
- Enrollment target
- 20
- Study locations
Study Summary
Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS. Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 220 sites worldwide. Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution. There may be 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 and bone marrow tests, checking for side effects, and completing questionnaires.
Primary Outcome
OS is defined as the number of days from the date of randomization to the date of death of any cause, or last known date to be alive.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Placebo
- DRUG Azacitidine
Study Locations (20)
Florida
- Florida Cancer Specialists - Fort Myers /ID# 221319 - Fort Myers
- Memorial Healthcare System /ID# 222703 - Hollywood
- Florida Cancer Specialists - North /ID# 221318 - St. Petersburg
- Florida Cancer Specialists - Panhandle /ID# 221315 - Tallahassee
- Florida Cancer Specialists - East /ID# 221317 - West Palm Beach
California
- Duplicate_Providence Medical Foundation /ID# 222633 - Fullerton
- University of California, Los Angeles /ID# 221760 - Los Angeles
- Torrance Memorial Physician Network Cancer Care /ID# 222702 - Torrance
- PIH Health Whittier Hospital /ID# 222647 - Whittier
Illinois
- Northwestern University Feinberg School of Medicine /ID# 220843 - Chicago
- Duplicate_Rush University Medical Center /ID# 221007 - Chicago
- Ingalls Memorial Hosp /ID# 220844 - Harvey
- Illinois Cancer Care, PC /ID# 220840 - Peoria
Colorado
- Rocky Mountain Cancer Centers - Boulder /ID# 223723 - Boulder
Connecticut
- Yale University School of Medicine /ID# 222764 - New Haven
Delaware
- Helen F. Graham Cancer Center & Research Institute /ID# 223731 - Newark
Idaho
- St. Luke's Mountain State Tumor Institute /ID# 220838 - Boise
Indiana
- Duplicate_Parkview Cancer Institute /ID# 223620 - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 531 participants |
| Start Date | 2020-09-10 |
| Est. Completion | 2026-03 |
| Phase | Phase 3 |
What the registry record for NCT04401748 still lists
NCT04401748 is an interventional study that assigns participants to a tested intervention. The registered 531 participants enrollment target is mid-sized for trials with a published cap, above the 58-participant average among 19 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (816% higher).
The record links to 1 condition, with Myelodysplastic Syndrome (MDS) appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT04401748 names 20 study sites across 10 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT04401748 about?
NCT04401748 is a clinical study titled "Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome". Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and...
What is the current status of trial NCT04401748?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 531 participants. The study started on 2020-09-10. Estimated completion is 2026-03.
What conditions does trial NCT04401748 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome (MDS).
What interventions are being tested in trial NCT04401748?
The interventions under investigation include: Venetoclax (DRUG), Placebo (DRUG), Azacitidine (DRUG).
Who is sponsoring clinical trial NCT04401748?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04401748 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04401748's enrollment target sits among peer trials
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