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This phase III trial is conducted to evaluate if azacitidine in combination with venetoclax as maintenance therapy improves relapse-free survival (RFS) for younger adults with favorable-risk acute myeloid leukemia (AML) who remained in first complete remission (CR1) following intensive consolidation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (azacytidine+venetoclax) | Experimental | Participants will receive azacytidine QD, on Days 1-5 and venetoclax QD, on Days 1-14 of each 28-day cycle for 8 cycles. |
|
| Comparator ( best supportive care) | Experimental | Participants will receive observation and supportive care during remission. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azacitidine | Drug | Given SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free survival (RFS) | RFS is defined as the number of days from CR/CRi to the date of relapse or the date of death from any cause, whichever comes first. | From date of complete remission (CR) or complete remission with incomplete count recovery (CRi), to relapse or death from any cause, up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD) Negative Conversion | The MRD conversion rate is defined as the percentage of participants deemed MRD positive (≥ 10^-3) at study initiation who converted to MRD of < 10^-3 in the bone marrow after randomization or initiation of treatment. | Measured From Baseline to approximately 3 years |
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Inclusion Criteria:
Diagnosis of favorable-risk acute myeloid leukemia (AML) according to revised 2017 European LeukemiaNet genetic risk stratification and are not immediate candidates for allogeneic stem cell transplant.
Aged 18-64 years.
Patients who have received remission induction therapy and 3-4 HiDAC or medium-dose cytarabine-based consolidation and are in their first remission.
ECOG performance status of < or = 3.
Adequate organ function as follows:
For females of childbearing age, they should have a negative serum or urine pregnancy test within 10 to 14 days of enrolling.
For males of childbearing age, they should take effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment.
Ability to understand and sign informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suning Chen | Contact | +86-13814881746 | chensuning@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Suning Chen | First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| C579720 | venetoclax |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Venetoclax | Drug | Given PO |
|
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| Supportive care | Other | Patients will receive disease monitoring and supportive care for any complication. |
|
| Complete remission duration (CRd) | CRd is defined as time from CR/CRi until date of confirmed relapse | From date of CR/CRi to approximately 3 years |
| Overall Survival (OS) | OS is defined as the number of days from the date of study treatment to the date of death. | Time from treatment to death from any cause, up to approximately 3 years |
| Event free survival (EFS) | EFS is defined as time from the start of study treatment until date of first confirmed relapse, withdrawal from study due to adverse event, or death due to any cause, | Time from treatment to relapse，withdrawal from study due to adverse event and death from any cause, up to approximately 3 years |
| Incidence of adverse events | The NCI Common Toxicity Criteria (CTCAE 5.0) is used to grade adverse events. | Time from treatment to approximately 3 years |
| The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology | Recruiting | Suzhou | Jiangsu | 215000 | China |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |