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The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed acute myeloid leukemia.
Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor. In order to improve the outcome of patients with de novo AML, participants developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, participants intent to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed AML.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Experimental: Venetoclax combined CACAG regimen for newly diagnosed AML. All recipients in this arm received azacytidine, cytarabine.aclamycin, chidamide,venetoclax and granulocyte colony-stimulating factor.Azacytidine was uesd as 75 mg/m2/day from day-1 to day-7.Cytarabine was uesd as 75 mg/m2 bid from day-1 to day-5. Aclamycin was uesd as 10 mg/m2/day on day1,3,5). Chidamide was uesd as 30 mg/day twice per week for 2 weeks. Venetoclax was uesd as 100 mg on day 1, 200 mg on day 2, 400mg from day-3 to day-14.Granulocyte colony-stimulating factor was uesd as 5ug/kg/day from day 0 until agranulocytosis recovery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| azacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Defined as the percentage of participants achieving a best overall response of complete response (CR), CR with incomplete blood count recovery (CRi), or partial response (PR). | 1 month after study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Minimal Residual Disease (MRD)-Negative Response: | Percentage of participants who achieved MRD-negative response, defined as < 1 leukemia cell per 10,000 leukocytes as assessed by flow cytometry or < 0.01% as assessed by PCR of a bone marrow aspirate. | after two courses of chemotherapy (each course is 28 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daihong Liu Liu, doctor | Chinese PLA General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40079007 | Derived | Liu Q, Yang J, Lv L, Zhang X, Li M, Xu L, Huang S, Jing Y, Dou L. Phase 2 study of chidamide in combination with CAG and venetoclax-azacitidine in older patients with newly diagnosed acute myeloid leukemia. Front Immunol. 2025 Feb 26;16:1525110. doi: 10.3389/fimmu.2025.1525110. eCollection 2025. |
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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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|
| Progression Free Survival (PFS) |
PFS was defined as time from the date joining the clinical study to the date of disease progression (PD) or date of death due to any cause, whichever occurred first. |
| 180 days after study treatment |
| Overall Survival (OS) | Defined as the time from joining the clinical study to death due to any cause. | 180 days after study treatment |
| Rate of Participants With Adverse Events | Percentage of Participants with 3 or 4 grade Adverse Events reported through 28 days post last study medication administration. | Through 28 days post last study medication administration |
| Partial Remission (PR) Rate: | All hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25 percent; and decrease of pre-treatment bone marrow blast percentage by at least 50 percent. | 1 month after study treatment |
| Complete Remission (CR) Rate | Defined in accordance with the IWG Response Criteria in AML. Bone marrow blasts &lt;5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count &gt;1.0 x 109/L (1000/µL); platelet count &gt;100 x 109/L (100,000/µL); independence of red cell transfusions. | 1 month after study treatment |
| CR with Incomplete Blood Count Recovery Rate | All CR criteria except for residual neutropenia (&lt;1.0 x 109/L (1000/µL)) or thrombocytopenia (&lt;100 x 109/L (100,000/µL) | 1 month after study treatment |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |