NCT04964505

Uproleselan, Azacitidine, and Venetoclax for the Treatment of Treatment Naive Acute Myeloid Leukemia

Terminated Phase 1 Last updated 23 February 2026

What this trial tests

Phase 1 trial testing Azacitidine in Acute Myeloid Leukemia in 16 participants. Terminated before completion.

Timeline

2 July 2021

Primary endpoint
4 October 2024

7 October 2025

Quick facts

Lead sponsor	Brian Jonas
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	2 July 2021
Primary completion	4 October 2024
Estimated completion	7 October 2025
Sites	1 location across United States

Drugs / interventions tested

• Azacitidine (azacitidine) — full drug profile →
• Uproleselan — full drug profile →
• Venetoclax (venetoclax) — full drug profile →

Conditions studied

• Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

Brian Jonas

Who can join

18 and older, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial evaluates the side effects of uproleselan, azacitidine, and venetoclax in treating older or unfit patients with treatment naive acute myeloid leukemia. Uproleselan may help block the formation of growths that may become cancer. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving uproleselan with azacitidine and venetoclax may help kill more cancer cells.

Publications & conference data

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

1. Recent advances in targeted therapies in acute myeloid leukemia.
   Bhansali RS, Pratz KW, Lai C. · · 2023 · cited 151× · PMID 36966300 · DOI 10.1186/s13045-023-01424-6
2. P- and E- selectin in venous thrombosis and non-venous pathologies.
   Purdy M, Obi A, Myers D, Wakefield T. · · 2022 · cited 60× · PMID 35243742 · DOI 10.1111/jth.15689
3. Venetoclax: A New Partner in the Novel Treatment Era for Acute Myeloid Leukemia and Myelodysplastic Syndrome.
   El-Cheikh J, Bidaoui G, Saleh M, Moukalled N, et al · · 2023 · cited 22× · PMID 37071328 · DOI 10.1007/s44228-023-00041-x
4. How We Incorporate Venetoclax in Treatment Regimens for Acute Myeloid Leukemia.
   Maiti A, Konopleva MY. · · 2022 · cited 19× · PMID 35072368 · DOI 10.1097/ppo.0000000000000567
5. Building on Foundations: Venetoclax-Based Combinations in the Treatment of Acute Myeloid Leukemia.
   Oyogoa E, Traer E, Tyner J, Lachowiez C. · · 2023 · cited 16× · PMID 37509251 · DOI 10.3390/cancers15143589
6. Targeting hematologic malignancies by inhibiting E-selectin: A sweet spot for AML therapy?
   Uy GL, DeAngelo DJ, Lozier JN, Fisher DM, et al · · 2024 · cited 7× · PMID 38493006 · DOI 10.1016/j.blre.2024.101184
7. Comprehensive view on chemotherapy-free management of acute myeloid leukemia by using venetoclax in combination with targeted and/or immune therapies.
   Kegyes D, Tat A, Vizitiu AS, Vazar-Tripon D, et al · · 2025 · cited 6× · PMID 40804253 · DOI 10.1038/s41420-025-02678-4
8. The PedAL/EuPAL Project: A Global Initiative to Address the Unmet Medical Needs of Pediatric Patients with Relapsed or Refractory Acute Myeloid Leukemia.
   Ceolin V, Ishimaru S, Karol SE, Bautista F, et al · · 2023 · cited 3× · PMID 38201506 · DOI 10.3390/cancers16010078