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| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
| West China Hospital | OTHER |
| Fujian Medical University Union Hospital | OTHER |
| The First Hospital of Jilin University |
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This study is to investigate the therapeutic efficacy and side effect of chidamide, azacitidine combined with priming HAG regimen for relapsed or refractroy acute myeloid leukemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chidamide+AZA+HHT+AraC+G-CSF group | Experimental | The patients are randomized into the group. Patients whose last induction failure regimen is a demethylated agent combined with priming regimen enter the experimental group directly. |
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| Placebo+AZA+HHT+AraC+G-CSF group | Placebo Comparator | The patients are randomized into the group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAHAG regimen | Drug | Chidamide 30mg orally twice every week for 2 weeks on days 1, 4, 8, 11, azacytidine 75mg/m2 intravenously daily for 7 days (d3-d9) and HAG regimen (cytarabine, 10 mg/m2 subcutaneously every 12 h on days 3-16; homoharringtonine, 1mg/m2 intravenously every day on days 3-16; and concurrent granulocyte colony-stimulating factor, 200mg/m2/day subcutaneously daily from days 2 to neutral granulocyte recovery. (when WBC > 20×10E9/L, G-CSF paused). One treatment cycle for 28 days, a total of 2 cycles. If the bone marrow assessment is MLFS on the 28th day in the first cycle, the second cycle of treatment will be started after NE<1.0×10E9/L; if the delay exceeds 2 weeks, the patient needs to withdraw from the trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | The overall response (completed remission without minimal residual disease, completed remission with incomplete blood count recovery, morphologic leukemia-free state and partial remission) rate achieved after one or two courses(28 days) induction therapy by CAHAG regimen. | At the end of Cycle 1 (each cycle is 28 days) |
| Complete remission without minimal residual disease (CR with MRD-) | If studied pretreatment, CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC | At the end of Cycle 1 (each cycle is 28 days) |
| Complete remission with incomplete hematologic recovery (CRi) | All CR criteria except for residual neutropenia (,1.0*10E9/L [1000/uL]) or thrombocytopenia (<100*10E9/L [100 000/uL]) | At the end of Cycle 1 (each cycle is 28 days) |
| Morphologic leukemia-free state (MLFS) | Bone marrow blasts ,5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required | At the end of Cycle 1 (each cycle is 28 days) |
| Partial remission (PR) | All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. | At the end of Cycle 1 (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | It is measured the time from initial response to subsequent disease progression or relapse. | 1 year |
| Overall Survival (OS) | It is measured from the time of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reactions in hematology | Record of adverse events in hematological system during and after CAHAG regimen induction (agranulocytosis days, PLT/RBC transfusion units). | At the end of Cycle 1 (each cycle is 28 days) |
| Nonhematological adverse reactions |
Inclusion Criteria:
A: Refractory AML disease was defined as follows: (1) failure to attain CR following exposure to at least 2 courses of standard or intensive induction therapy; or (2) bone marrow leukemia cell decline index (BMCDI) < 50% and > 20% after 1 course of standard or intensive induction therapy. B: Relapsed AML disease was defined as follows: (1) reappearance of leukemic blasts in the peripheral blood after CR; or (2) detection of ≥ 5% blasts in the BM not attributable to another cause (e.g., BM regeneration after consolidation therapy); or (3) extramedullary relapse.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | 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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| OTHER |
| Anhui Provincial Hospital | OTHER_GOV |
| Qilu Hospital of Shandong University | OTHER |
| Zhengzhou University | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Nanfang Hospital, Southern Medical University | OTHER |
| First Affiliated Hospital of Harbin Medical University | OTHER |
| Xinqiao Hospital of Chongqing | OTHER |
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| Placebo regimen | Drug | Chidamide 0mg orally twice every week for 2 weeks on days 1, 4, 8, 11, azacytidine 75mg/m2 intravenously daily for 7 days (d3-d9) and HAG regimen (cytarabine, 10 mg/m2 subcutaneously every 12 h on days 3-16; homoharringtonine, 1mg/m2 intravenously every day on days 3-16; and concurrent granulocyte colony-stimulating factor, 200mg/m2/day subcutaneously daily from days 2 to neutral granulocyte recovery. (when WBC > 20×10E9/L, G-CSF paused). One treatment cycle for 28 days, a total of 2 cycles. If the bone marrow assessment is MLFS on the 28th day in the first cycle, the second cycle of treatment will be started after NE<1.0×10E9/L; if the delay exceeds 2 weeks, the patient needs to withdraw from the trial. |
|
| 1 year |
| Progression-Free Survival (PFS) | It is measured from the time from randomization to progression or death. | 1 year |
Record of adverse events in other organs or systmes during and after CAHAG regimen induction (infection and organ injury).
| At the end of Cycle 1 (each cycle is 28 days) |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |