NCT05005299 (VICTORY) is a Phase 1 clinical trial of Venetoclax in Leukemia, Myeloid, Acute, sponsored by Melbourne Health.

Who is sponsoring NCT05005299?

NCT05005299 is sponsored by Melbourne Health.

What drugs are being tested in NCT05005299?

Interventions in NCT05005299: Venetoclax, Fludarabine, Cyclophosphamide.

What condition does NCT05005299 study?

NCT05005299 studies Leukemia, Myeloid, Acute, Leukemia, Lymphoblastic, Acute, L1, Leukemia, Lymphoblastic, Acute, L2, Myelodysplastic Syndromes, Non-hodgkin Lymphoma, Plasma Cell Myeloma.

Is NCT05005299 still recruiting?

NCT05005299 is currently status unknown. Last updated 1 August 2023.

Last reviewed 2023-08-01 · How we verify

NCT05005299: VICTORY

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

Venetoclax in Combination With Non-myeloablative Conditioning Allogeneic Haematopoietic Stem Cell Transplantation

Status unknown Phase 1 Last updated 1 August 2023

What this trial tests

Phase 1 trial testing Venetoclax in Leukemia, Myeloid, Acute in 18 participants. Status unknown.

Timeline

8 June 2022

Primary endpoint
31 March 2026

31 March 2026

Quick facts

Lead sponsor	Melbourne Health
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	8 June 2022
Primary completion	31 March 2026
Estimated completion	31 March 2026
Sites	1 location across Australia

Drugs / interventions tested

Venetoclax (venetoclax) — full drug profile →
Fludarabine (FLUDARABINE) — full drug profile →
Cyclophosphamide (cyclophosphamide) — full drug profile →

Conditions studied

Leukemia, Myeloid, Acute — all drugs for Leukemia, Myeloid, Acute →
Leukemia, Lymphoblastic, Acute, L1 — all drugs for Leukemia, Lymphoblastic, Acute, L1 →
Leukemia, Lymphoblastic, Acute, L2 — all drugs for Leukemia, Lymphoblastic, Acute, L2 →
Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →

Sponsor

Melbourne Health — full company profile →

Who can join

Adults 18 to 75, any sex, with Leukemia, Myeloid, Acute or Leukemia, Lymphoblastic, Acute, L1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1, open-label, single center study of short-course oral venetoclax therapy prior to non-myeloablative conditioning with fludarabine and cyclophosphamide in subjects with haematological malignancies who are planned for allogeneic stem cell transplantation (alloSCT). The primary study objective is to determine the safety and maximum tolerated dose of venetoclax when used in combination with fludarabine and cyclophosphamide conditioning. Secondary objectives were to evaluate the transplant outcomes and donor/recipient engraftment of this regimen.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

The Emerging Role of Venetoclax-Based Treatments in Acute Lymphoblastic Leukemia.
Aumann S, Shaulov A, Haran A, Gross Even-Zohar N, et al · · 2022 · cited 30× · PMID 36142863 · DOI 10.3390/ijms231810957
Smart Conditioning with Venetoclax-Enhanced Sequential FLAMSA + RIC in Patients with High-Risk Myeloid Malignancies.
Schulz F, Jäger P, Tischer J, Fraccaroli A, et al · · 2024 · cited 9× · PMID 38339283 · DOI 10.3390/cancers16030532
Innovations in conditioning and post-transplant maintenance in AML: genomically informed revelations on the graft-versus-leukemia effect.
Murdock HM, Ho VT, Garcia JS. · · 2024 · cited 6× · PMID 38571944 · DOI 10.3389/fimmu.2024.1359113
Is There (Still) a Place for Sequential Conditioning?
Bours B, Masouridi-Levrat S. · · 2025 · cited 1× · PMID 40277753 · DOI 10.3390/curroncol32040196

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 Leukemia, Myeloid, Acute

Currently open trials in the same condition.

NCT06852222 — A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leuke · Phase 3 · recruiting
NCT06651229 — A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms · Phase 1 · recruiting
NCT06618001 — A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms · Phase 1 · recruiting
NCT06643962 — Venetoclax Combined with Intensive Therapy for Acute Myeloid Leukemia Patients with Lower Early Peripheral Blast Clearan · NA · recruiting
NCT06382168 — DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia · Phase 1, PHASE2 · recruiting

Other Melbourne Health trials

Trials by the same sponsor.

NCT06607367 — REscuing Bone Marrow Function in Patients with AplaStic AnaEmia and Bone Marrow FaiLure Post AllogEneiC Transplantation · Phase 1, PHASE2 · not yet recruiting
NCT05923476 — Electroconvulsive Therapy and Concomitant Lithium in Depressive Disorder: A Pilot Study · EARLY_PHASE1 · unknown
NCT05742243 — Insulin and Abatacept in Recently-diagnosed Type 1 Diabetes · Phase 2 · completed
NCT05577416 — A Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma · EARLY_PHASE1 · completed
NCT04796636 — High-dose Intravenous Vitamin C in Patients With Septic Shock · Phase 1 · unknown

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 NCT05005299 (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 Melbourne Health
Last refreshed: 1 August 2023

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/NCT05005299.

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