NCT07469046 is a Phase 3 clinical trial of Venetoclax in Acute Myeloid Leukemia (AML), sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.

What drugs are being tested in NCT07469046?

Interventions in NCT07469046: Venetoclax, Azacitidine, Homoharringtonine.

What condition does NCT07469046 study?

NCT07469046 studies Acute Myeloid Leukemia (AML), Elderly Patients (60-75 Years).

Is NCT07469046 still recruiting?

NCT07469046 is currently not yet recruiting. Last updated 13 April 2026.

Last reviewed 2026-04-13 · How we verify

NCT07469046

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

VAH vs VA in Newly Diagnosed Elderly AML

Not yet recruiting Phase 3 Last updated 13 April 2026

What this trial tests

Phase 3 trial testing Venetoclax in Acute Myeloid Leukemia (AML) in 308 participants. Not yet recruiting.

Timeline

10 April 2026

Primary endpoint
31 March 2028

31 March 2029

Quick facts

Lead sponsor	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Phase	Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	308
Start date	10 April 2026
Primary completion	31 March 2028
Estimated completion	31 March 2029
Sites	1 location across China

Drugs / interventions tested

Venetoclax (venetoclax) — full drug profile →
Azacitidine (azacitidine) — full drug profile →
Homoharringtonine — full drug profile →

Conditions studied

Acute Myeloid Leukemia (AML) — all drugs for Acute Myeloid Leukemia (AML) →
Elderly Patients (60-75 Years) — all drugs for Elderly Patients (60-75 Years) →

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Who can join

Adults 60 to 75, any sex, with Acute Myeloid Leukemia (AML) or Elderly Patients (60-75 Years). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, open-label, randomized, controlled phase III clinical trial designed to evaluate the efficacy and safety of the combination of Venetoclax, Azacitidine, and Homoharringtonine (VAH) compared to Venetoclax and Azacitidine (VA) alone in newly diagnosed elderly patients with Acute Myeloid Leukemia (AML). A total of 308 treatment-naïve patients aged 60-75 years with AML (non-APL) will be enrolled and randomly assigned in a 1:1 ratio to either the control arm (VA) or the experimental arm (VAH). The study aims to determine if the addition of Homoharringtonine to the standard VA regimen can improve response rates. To mitigate bias in this open-label study, the primary and key secondary efficacy endpoints will be assessed by an Independent Review Committee or central laboratory blinded to treatment allocation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Venetoclax

Trials testing the same drug.

NCT07425808 — FLT3-ITD Targeted Therapy in Fit AML Patients · Phase 2, PHASE3 · not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting
NCT07175415 — HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological · Phase 1, PHASE2 · not yet recruiting
NCT07513129 — A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients · Phase 1 · not yet recruiting
NCT07511062 — Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML · Phase 1 · not yet recruiting

Other recruiting trials for Acute Myeloid Leukemia (AML)

Currently open trials in the same condition.

NCT07463651 — MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib · Phase 3 · recruiting
NCT07500441 — Digital PCR of CHIP and MR for MRD Monitoring After Allo-HSCT in AML · recruiting
NCT07410494 — Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT06707493 — Ivosidenib as Post-HSCT Maintenance for AML · Phase 2 · recruiting
NCT07458542 — Effectiveness and Safety of ONUREG (Oral Azacitidine) in Chinese Patients With Acute Myeloid Leukemia · active not recruiting

Other Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine trials

Trials by the same sponsor.

NCT06667466 — New Laser and Suction Sheath for Kidney Stone Treatment · not yet recruiting
NCT07043374 — Impact of Humid-Heat on Gut-Tryptophan-Stone Pathway · not yet recruiting
NCT07415226 — Glucose-lowering Drugs as an Adjunct to Insulin Therapy in Chinese Patients With Type 1 Diabetes · not yet recruiting
NCT07439120 — Safety and Tolerability Study of 68Ga/177Lu-BRP-020063 in Advanced Solid Tumors · EARLY_PHASE1 · not yet recruiting
NCT07371520 — Application of Quantitative Hemorrhage Detection in Fetomaternal Hemorrhage Syndrome for the Diagnosis of Hemolytic Dise · not yet 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 NCT07469046 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Last refreshed: 13 April 2026

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/NCT07469046.

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