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| Name | Class |
|---|---|
| 940 Hospital of the People's Liberation Army Joint Logistic Support Force | OTHER |
| The General Hospital of Western Theater Command | OTHER |
| First Affiliated Hospital of Harbin Medical University | OTHER |
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This study is a multicenter, prospective, randomized, controlled clinical trial, observing the efficacy and safety of the CACAG+Venetoclax regimen (Chidamide + Azacitidine + Aclarubicin + Cytarabine + Recombinant Human Granulocyte Colony-Stimulating Factor + Venetoclax) in elderly patients with newly diagnosed Acute Myeloid Leukemia (AML). The control group applies the standard "3+7" regimen. The aim is to improve the remission rate of AML patients, reduce the probability of adverse events, and thereby improve patient prognosis and extend patient survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax Combined With CACAG Regimen | Experimental | The entire treatment period for the CACAG+Venetoclax regimen in the trial is 2 week, with a treatment cycle of every 4 weeks, and a total of 2 course of treatment. Chidamide: 30 mg, twice a week, for a total of 4 administrations; Azacitidine: 75 mg/m^2 from day 1 to day 7; Cytarabine (Ara-C): 75-100 mg/m^2 every 12 hours from day 1 to day 7; Aclarubicin: 20 mg/m^2 on days 1, 3, and 5; Recombinant human granulocyte colony-stimulating factor (G-CSF): 300 μg/day, to be discontinued when neutrophils recover and white blood cell count is ≥20,000/μL; Venetoclax: 100 mg on day 1, 200 mg on day 2, 400 mg from day 3 to day 14, used in combination with azoles, with a reduced dosage of 100 mg/day. |
|
| the standard "3+7" regimen | Active Comparator | IA Regimen: Idarubicin: 8-12 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. Or DA Regimen: Daunorubicin: 60 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. Or MA Regimen: Mitoxantrone: 6-10 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the standard "3+7" regimen | Drug | IA Regimen: Idarubicin: 8-12 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. Or DA Regimen: Daunorubicin: 60 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. Or MA Regimen: Mitoxantrone: 6-10 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Complete Remission (CRc) Rate after 1 course of treatment | a combination of complete remission (CR) and complete remission with incomplete blood count recovery (CRi) | 1 months after study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) after 1 course of treatment | 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).Biological characteristics exploratory studies were analyzed by single-cell sequencing and Atac-seq. Further, according to European LeukemiaNet risk group, we analyzed the outcomes of patients by molecular subtype as a sub-group analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dahong Liu Liu, doctor | Contact | +8613681171597 | daihongrmg@163.com | |
| Liping Dou, Doctor | Contact | +8613681207138 | lipingruirui@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Dahong Liu, Doctor | Chinese PLA General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | None Selected | 100853 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 18, 2024 | Mar 31, 2026 |
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| 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China | OTHER |
randomized, controlled clinical trial,
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|
| Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; Granulocyte | Drug | IA Regimen: Idarubicin: 8-12 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. Or DA Regimen: Daunorubicin: 60 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. Or MA Regimen: Mitoxantrone: 6-10 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. |
|
| 1 months after the start of study treatment |
| Complete Remission (CR) Rate after 1 courses of treatment | Defined in accordance with the IWG Response Criteria in AML. Bone marrow blasts<5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0 x 10^9/L (1000/µL); platelet count >100 x 109/L (100,000/µL); independence of red cell transfusions. | after 1 courses of chemotherapy (each course is 28 days) |
| 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 after each courses of chemotherapy (each course is 28 days) | after each courses of chemotherapy (each course is 28 days) |
| Event-free survival | Defined as the time interval from treatment initiation to the occurrence of induction failure,relapse,or death,whichever came first. | 180 days after study treatment |
| Overall Survival | Defined as the time from joining the clinical study to death due to any cause. | 180 days after study treatment |
| Treatment-related adverse events | Defined as adverse events that occurred from the first dose of study treatment to 30 days after the discontinuation of treatment. | From the first dose of study treatment to 30 days after the discontinuation of treatment |
| Disease-free survival | Defined as the time interval from disease remission to the occurrence of relapse or death,whichever came first. | 180 days after study treatment Outcome Measure |
| Early death | Defined as death within 30 days of chemotherapy. | Within 30 days of the start of the first course of treatment |
| Complete Remission with Incomplete Blood Count Recovery (CRi)after 1 courses of treatment | Disappearance of leukemia blasts in the bone marrow (<5% blasts) but without full recovery of blood counts (neutrophils <1.0 x 10⁹/L and/or platelets <100 x 10⁹/L). | after 1 courses of chemotherapy (each course is 28 days |
| ICF_000.pdf |
| 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 |
|---|---|
| D001374 | Azacitidine |
| D003561 | Cytarabine |
| C011157 | aclacinomycins |
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| C579720 | venetoclax |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D001087 | Arabinonucleosides |
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