Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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
NCT04401748 · View on ClinicalTrials.gov ↗
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.
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04401748
The ClinicalTrials.gov registry entry for NCT04401748 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 531 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 Myelodysplastic Syndrome (MDS) appearing as the primary indexed condition, and to 3 interventions — of which Venetoclax 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: NCT04401748 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Illinois. 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 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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04401748?
The interventions under investigation include: Venetoclax (DRUG), Placebo (DRUG), Azacitidine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04401748?
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 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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.