NCT05939180 is a Phase 2, PHASE3 clinical trial of Venetoclax Oral Tablet in Acute Myeloid Leukemia, sponsored by The First Affiliated Hospital of Soochow University.

Who is sponsoring NCT05939180?

NCT05939180 is sponsored by The First Affiliated Hospital of Soochow University.

What drugs are being tested in NCT05939180?

Interventions in NCT05939180: Venetoclax Oral Tablet, Daunorubicin.

What condition does NCT05939180 study?

NCT05939180 studies Acute Myeloid Leukemia.

Is NCT05939180 still recruiting?

NCT05939180 is currently recruiting now. Last updated 9 April 2024.

Last reviewed 2024-04-09 · How we verify

NCT05939180

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

VA vs DA for Newly Diagnosed Hig-risk AML

Recruiting now Phase 2, PHASE3 Last updated 9 April 2024

What this trial tests

Phase 2, PHASE3 trial testing Venetoclax Oral Tablet in Acute Myeloid Leukemia in 116 participants. Currently enrolling.

Timeline

1 April 2024

Primary endpoint
1 October 2025

1 October 2027

Quick facts

Lead sponsor	The First Affiliated Hospital of Soochow University
Phase	Phase 2, PHASE3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	116
Start date	1 April 2024
Primary completion	1 October 2025
Estimated completion	1 October 2027
Sites	2 locations across China

Drugs / interventions tested

Venetoclax Oral Tablet — full drug profile →
Daunorubicin (daunorubicin) — full drug profile →

Conditions studied

Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

The First Affiliated Hospital of Soochow University

Who can join

Adults 18 to 64, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, multicenter, phase 2b, randomized study aiming to compare the efficacy and safety of venetoclax plus azacytidine Versus daunorubicin plus cytarabine (conventional 7+3 regimen) in adult acute myeloid leukemia (AML) patients with adverse risk featuress. Participants will be 1:1 randomly assigned to the VA and DA groups. Once remission was achieved, consolidated chemotherapy will be performed and allogeneic hematopoietic stem cell transplantation is strongly recommended. After completion of the study intervention, participants will be followed-up every 1 to 2 months for up to 2 years.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Venetoclax and hypomethylating agents versus induction chemotherapy for newly diagnosed acute myeloid leukemia patients: a systematic review and meta-analysis.
Liu Y, Zhang Y, Gao J, Wang L, et al · · 2025 · cited 2× · PMID 40389911 · DOI 10.1186/s12885-025-14311-9

Verify or expand the search:

Other trials of Venetoclax Oral Tablet

Trials testing the same drug.

NCT06087419 — A Prospective Clinical Study of Bridging alloHSCT After Treatment With Obinutuzumab in Combination With Chidamide and Ve · Phase 1, PHASE2 · unknown

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I · Phase 2 · recruiting
NCT07177079 — High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML · Phase 1 · recruiting
NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
NCT07107126 — Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes · Phase 1 · recruiting

Other The First Affiliated Hospital of Soochow University trials

Trials by the same sponsor.

NCT07350863 — U69-CART-Cells For R/R T-ALL · Phase 1 · recruiting
NCT06985498 — Immunotherapy Combined With Auto-HSCT and CD22/CD19 CAR-T Sandwich Strategy for B-ALL · Phase 2 · not yet recruiting
NCT07463651 — MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib · Phase 3 · recruiting
NCT07500753 — A Single-arm, Prospective Study of a Clad-LABU Conditioning Regimen in HSCT for R/R MDS/AML in Elderly Patients · NA · recruiting
NCT07511426 — U96-CAR-T-Cells For R/R B-ALL · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05939180 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital of Soochow University
Last refreshed: 9 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05939180.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing