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A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
NCT04102020 · View on ClinicalTrials.gov ↗
Study Summary
This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA). Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with AZA. Part 2 and Part 3 Randomization of the study were removed.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
Study Locations (20)
Massachusetts
- Tufts Medical Center /ID# 216110 — Boston
- Massachusetts General Hospital /ID# 217307 — Boston
- Duplicate_UMass Chan Medical School /ID# 218163 — Worcester
California
- Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156 — Fountain Valley
- University of California, Los Angeles /ID# 219149 — Los Angeles
Kentucky
- University of Kentucky Markey Cancer Center /ID# 215048 — Lexington
- Duplicate_Norton Cancer Institute /ID# 216401 — Louisville
Louisiana
- Tulane Medical Center - New Orleans /ID# 218166 — New Orleans
- Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 214583 — New Orleans
Missouri
- Oncology Hematology Associates (OHA) - Springfield /ID# 216351 — Springfield
- Saint Louis University Cancer Center /ID# 218164 — St Louis
New Jersey
- The John Theurer Cancer /ID# 215191 — Hackensack
- Rutgers Cancer Institute of New Jersey /ID# 239708 — New Brunswick
Alabama
- Mitchell Cancer Institute /ID# 216443 — Mobile
Colorado
- Colorado Blood Cancer Institute /ID# 214280 — Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2020-03-26 |
| Est. Completion | 2026-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04102020
The ClinicalTrials.gov registry entry for NCT04102020 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 112 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 Acute Myeloid Leukemia (AML) appearing as the primary indexed condition, and to 2 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: NCT04102020 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Massachusetts, California, Kentucky. 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 NCT04102020 about?
NCT04102020 is a clinical study titled "A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy". This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA). Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with AZA. Part 2 and Part 3...
What is the current status of trial NCT04102020?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 112 participants. The study started on 2020-03-26. Estimated completion is 2026-06.
What conditions does trial NCT04102020 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia (AML). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04102020?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04102020?
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 NCT04102020 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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