NCT04964505

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

A Phase I Study of Uproleselan Combined With Azacitidine and Venetoclax for the Treatment of Older or Unfit Patients With Treatment Naive Acute Myeloid Leukemia

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Brian Jonas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To assess the safety and tolerability of uproleselan combined with azacitidine and venetoclax in older or unfit patients with treatment naive acute myeloid leukemia (AML). SECONDARY OBJECTIVE: I. To evaluate the preliminary efficacy of uproleselan combined with azacitidine and venetoclax in older or unfit patients with treatment naive AML. OUTLINE: Patients receive uproleselan intravenously (IV) over 1 hour every 12 hours (Q12H) on days 1-7, azacitidine IV or subcutaneously (SC) once daily (QD) on days 1-7, and venetoclax orally (PO) QD on days 1-28. Beginning cycle 5, patients achieving morphologic leukemia-free state (MLFS) or better response, may receive azacitidine IV or SC QD and uproleselan IV over 1 hour QD on days 1-6 and 8 or days 1-5 and 8-9 or days 1-5. Treatment with uproleselan repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Cycles with azacitidine and venetoclax repeat every 28 days in the absence of disease progression and unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, and then every 3 months for 1 year.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Azacitidine	Given IV or SC
DRUG	Uproleselan	Given IV
DRUG	Venetoclax	Given PO

Timeline

• Start date: 2021-07-02
• Primary completion: 2024-10-04
• Completion: 2025-10-07
• First posted: 2021-07-16
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study