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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 |
| The General Hospital of Northern Theater Command | OTHER |
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The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with BAT regimen in the treatment of relapsed/refractory acute myeloid leukemia.
Despite advances in therapies for acute myeloid leukemia (AML) in the past decades, some patients still suffer from relapsed/refractory (R/R) disease, resulting in poor outcomes. With a median overall survival (OS) of 4-7 months under classic chemotherapy approaches, it is imperative to explore new treatment options.Accumulating research has demonstrated the importance of epigenetic modification in the pathogenesis of chemoresistance. Recent studies have shown that combining venetoclax with hypomethylating agents (HMAs) such as azacitidine, or low-dose cytarabine (LDAC) improves the response and survival rates in R/R AML patients. To enhance the response rate, we designed a regimen that combines chidamide, azacitidine, cytarabine, aclarubicin, and G-CSF with venetoclax (CACAG+VEN regimen) for the treatment of patients with R/R AML. In this study, we intend to compare the efficacy and safety of venetoclax combined with the CACAG regimen with Best-Available Therapy(BAT) regimen in the treatment of relapsed/refractory acute myeloid leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax Combined With CACAG Regimen | Experimental | Venetoclax combined with CACAG regimen for relapsed/refractory AML. Recipients were randomized and those entering the experimental group received azacytidine,cytarabine,aclacinomycin,chidamide,venetoclax and granulocyte colony-stimulating factor. Azacytidine was used as 75 mg/m2/day from day 1 to day 7.Cytarabine was used as 75-100 mg/m2 bid from day 1 to day 5. Aclacinomycin was used as 20 mg/day on days 1,3,5. Chidamide was used as 30 mg/day on days 1,4,8,11. Venetoclax was used as 400 mg/day from day 1 to day 14.Granulocyte colony-stimulating factor was used as 300 ug/day from day 0 until agranulocytosi recovery. |
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| Best-Available Therapy(BAT) Regimen | Active Comparator | BAT regimen for relapsed/refractory AML.Recipients were randomized and those entering this group received FLAG/CLAG/MAE/DCAG/HAA/HAD regimen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor | Drug |
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| 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. | 1 months after the start of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission (CR) Rate after 1 course 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 109/L (1000/µL); platelet count >100 x 109/L (100,000/µL); independence of red cell transfusions. | 2 months after study treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daihong Liu, doctor | Contact | +8613681171597 | daihongrm@163.com | |
| Liping Dou, doctor | Contact | +8613681207138 | lipingruirui@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Daihong Liu, doctor | Chinese PLA General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China | OTHER |
| Air Force Military Medical University, China | OTHER |
| Yantai Yuhuangding Hospital | OTHER |
| People's Liberation Army (PLA) Strategic Support Force Characteristic Medical Center | UNKNOWN |
| First Hospital of China Medical University | OTHER |
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| Best-Available Therapy(BAT) Regimen | Drug |
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| Complete Remission (CR) Rate after 2 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 109/L (1000/µL); platelet count >100 x 109/L (100,000/µL); independence of red cell transfusions. | After two courses of chemotherapy (each course is 28 days) |
| Overall Response Rate (ORR) after 2 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. | After two 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 two 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 (OS) | 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 |
| Early death | Defined as death within 30 days of chemotherapy. | Within 30 days of the start of the first course 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 |
| 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 |
|---|---|
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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