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The goal of this clinical trial is to learn if a treatment combination-venetoclax plus hypomethylating agents (like azacitidine or decitabine) and low-dose cytarabine-works to treat adults with newly diagnosed CEBPA-mutated acute myeloid leukemia (AML) who can't tolerate intensive chemotherapy. It will also check how safe this treatment combination is and explore how the disease might change if it comes back. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax + Hypomethylating Agents + Low-Dose Cytarabine for CEBPA-Mutated AML (Unfit Patients) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax + Hypomethylating Agents + Low-Dose Cytarabine for CEBPA-Mutated AML (Unfit Patients) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-Free Survival (RFS) | Defined as the time from the date of achieving complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) to the first occurrence of disease relapse (reappearance of ≥5% blasts in the bone marrow, presence of blasts in the peripheral blood, or new extramedullary disease) or death from any cause, whichever comes first. For participants who remain in remission at the end of the follow-up period, RFS is censored at the date of the last confirmed remission assessment. | From date of achieving CR/CRi until first occurrence of disease relapse or death from any cause, assessed up to 48 months (2 years after the last patient has been enrolled into the study). |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Remission Rate after 2 Induction Cycles | Proportion of participants who achieve CR or CRi after completing 2 cycles of induction therapy. (Each cycle is 28 days) CR: Defined by the following criteria simultaneously: bone marrow blasts <5%, no blasts in the peripheral blood, absolute neutrophil count >1.0×10⁹/L, platelet count >100×10⁹/L, no extramedullary infiltration, and no relapse within 4 weeks. CRi: Meets all CR criteria except for incomplete hematologic recovery (absolute neutrophil count ≤1.0×10⁹/L or platelet count ≤100×10⁹/L). |
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Inclusion Criteria:
Patients can participate in this study only if they meet all the following enrollment criteria:
Aged over 18 years, male, or female who is neither pregnant nor lactating;
Newly diagnosed acute myeloid leukemia (AML) with CEBPA mutation;
ECOG performance status ≤ Grade 3;
Capable of understanding and willing to participate in the study, and able to sign the informed consent form;
Patients are judged as "unfit" according to the Ferrara criteria. A patient is considered "unfit" if they meet at least one of the following criteria:
Advanced age: > 75 years old;
Presence of severe underlying comorbidities involving the heart, lungs, kidneys, or liver; ③ Presence of active infection unresponsive to anti-infective treatment;
Exclusion Criteria:
Patients are not suitable for participating in this study if they meet any of the following exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suning Chen | Contact | 008613814881746 | chensuning@sina.com | |
| Wenzhi Cai | Contact | 008615106202752 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
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|
| Proportion of participants who achieve CR or CRi after completing 2 cycles of induction therapy. (Each cycle is 28 days) |
| Minimal Residual Disease (MRD) Negativity Rate | Proportion of participants with MRD <1×10-⁴ detected by flow cytometry after treatment. | 21 to 28 days after the end of every treatment |
| Duration of Remission (DOR) | If no relapse or death occurs during follow-up, DOR is censored at the last follow-up date. | From date of achieving CR/CRi until first occurrence of disease relapse or death from any cause, assessed up to 60 months. |
| Relapse Rate | Proportion of participants who experience disease relapse after achieving CR/CRi during the study period. | Proportion of participants who experience disease relapse after achieving CR/CRi, assessed up to 48 months (2 years after the last patient has been enrolled into the study). |
| Overall Survival (OS) | Time from the start of treatment to death from any cause. For participants who remain alive at the end of the follow-up period, OS is censored at the date of the last survival confirmation. | From start of treatment until death from any cause, assessed up to 48 months (2 years after the last patient has been enrolled into the study). |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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