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NCT04102020 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Acute Myeloid Leukemia (AML), sponsored by AbbVie.

Active
Registry status
Phase 3
Development phase
112
Enrollment target
20
Study locations

NCT04102020: Active Phase 3 study of Acute Myeloid Leukemia (AML), sponsored by AbbVie.

NCT04102020 is a Phase 3 study of Acute Myeloid Leukemia (AML) that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 112 participants, below the 142-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04102020, a Phase 3 study of Acute Myeloid Leukemia (AML), is active but no longer recruiting, sponsored by AbbVie.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
112 participants
Enrollment target
20
Study locations

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.

Primary Outcome

DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax as described in the protocol and evaluated by the Investigator and the sponsor.

Conditions Studied

Acute Myeloid Leukemia (AML)

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

FieldValue
Enrollment Target 112 participants
Start Date 2020-03-26
Est. Completion 2026-06
Phase Phase 3
AbbVie

526 total trials

What the registry record for NCT04102020 still lists

NCT04102020 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 142-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (21% lower).

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.

NCT04102020 names 20 study sites across 13 states, led by Massachusetts, California, Kentucky.

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).

What interventions are being tested in trial NCT04102020?

The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG).

Who is sponsoring clinical trial NCT04102020?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Acute Myeloid Leukemia (AML)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04102020's enrollment target sits among peer trials

112 9th of 29 higher than 21 of 29 other Acute Myeloid Leukemia (AML) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Myeloid Leukemia (AML) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04102020, the US trial registry maintained by the National Library of Medicine. NCT04102020 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.