NCT05144243 · ClinicalTrials.gov record · last posted 2025-08-12
Study to Assess Adverse Events and Change in Disease State of Oral Venetoclax in Combination With Subcutaneous (SC) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy in China
StatusActive, Not Recruiting
PhasePhase 4
Started2022-01-06
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Record status
This record was last updated August 12, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low survival rate and few options for participants who are unable to undergo intensive chemotherapy, the current standard of care. This study is to evaluate how safe the combination of azacitidine and venetoclax is and how effective the combination of azacitidine and venetoclax is in adult participants with acute myeloid leukemia (AML), in China. Adverse events and change in disease state will be assessed.
The combination of azacitidine and venetoclax is being evaluated in the treatment of acute myeloid leukemia (AML). Participants will receive azacitidine with increasing doses of venetoclax. Adult participants with a diagnosis of AML will be enrolled. Around 40 participants will be enrolled in the study in approximately 30 sites in China.
At cycle 1 during ramp-up period, participants will receive venetoclax oral tablets once daily in increasing doses until the study dose is achieved on day 3. Then ventoclax oral tablets will continue once daily thereafter. Azacitidine will be given by subcutaneous injection (SC) for 7 days beginning on Day 1 of each 28-day cycle.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
Amendment record
20 amendments on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended 20 times since 2021-11-22; most recent amendment 2025-08-08. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
See every version on ClinicalTrials.gov ↗
2022-10-26
Status change Recruiting→Active, Not Recruitingv15
2022-01-10
Status change Not Yet Recruiting→Recruitingv1
| NCT Number |
NCT05144243 |
| Lead Sponsor |
AbbVie
Collaborators: Genentech, Inc. |
| Conditions |
Acute Myeloid Leukemia (AML) |
| Enrollment |
44 participants |
| Start Date |
2022-01-06 |
| Primary Completion |
2026-03 (estimated) |
| Study Completion |
2026-03 (estimated) |
| Updated on ClinicalTrials.gov |
2025-08-12 |