Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT04964505
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-01
First Post:
2021-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Uproleselan, Azacitidine, and Venetoclax for the Treatment of Treatment Naive Acute Myeloid Leukemia
Sponsor:
Brian Jonas
Organization:
Study Overview
Official Title:
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-06216 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| UCDCC#294 | OTHER | University of California Davis Comprehensive Cancer Center | View | |
| P30CA093373 | NIH | None | https://reporter.nih.gov/quic… | View |