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This is a phase II/III, multicenter, randomized, three-arm, open-label, parallel controlled trial. The primary objective of this study is to compare the 2-years EFS rate of the LDA, LHAA, and DA regimens in newly diagnosed patients with low-risk acute myeloid leukemia who are eligible for intensive chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Lisaftoclax+Daunorubicin+Cytarabine | Experimental | Participants received induction chemotherapy with lisaftoclax, daunorubicin, and cytarabine. Patients achieving partial response (PR) with a reduction in bone marrow blasts >60% were allowed to receive one additional cycle of the same regimen. Patients who achieved complete response received consolidation therapy with lisaftoclax in combination with intermediate-dose cytarabine for 3 cycles. After completion of consolidation therapy, next-generation sequencing (NGS) was performed. Patients with minimal residual disease (MRD) negativity did not receive maintenance therapy, whereas patients with MRD positivity proceeded to maintenance therapy. Maintenance therapy consisted of lisaftoclax in combination with azacitidine, administered for up to 1 year or 10 cycles, whichever occurred first. |
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| Arm B: Lisaftoclax+homoharringtonine+cytarabine+aclarubicin | Experimental | Participants received induction chemotherapy with lisaftoclax, homoharringtonine, cytarabine, and aclarubicin. Patients achieving partial response (PR) with a reduction in bone marrow blasts >60% were allowed to receive one additional cycle of the same regimen. Patients who achieved complete response received consolidation therapy with lisaftoclax in combination with intermediate-dose cytarabine for 3 cycles. After completion of consolidation therapy, next-generation sequencing (NGS) was performed. Patients with minimal residual disease (MRD) negativity did not receive maintenance therapy, whereas patients with MRD positivity proceeded to maintenance therapy. Maintenance therapy consisted of lisaftoclax in combination with azacitidine, administered for up to 1 year or 10 cycles, whichever occurred first. |
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| Arm C: Daunorubicin+cytarabine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisaftoclax+daunorubicin+cytarabine | Drug | Lisaftoclax (200 mg on D2, 400 mg on D3, and 600 mg qd on D4-8, orally) + daunorubicin (60 mg/m², iv, qd, D1-3) + cytarabine (100 mg/m², q12h, subcutaneous injection or iv infusion, D1-7). |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year event-free survival (EFS) rate | defined as the proportion of patients remaining free of treatment failure, hematologic relapse, MRD relapse, or death within 2 years after randomization. | from randomization up to 2 years after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) rate after 1/2 treatment cycles | defined as the proportion of patients achieving complete response (CR) after the first or second cycle of induction chemotherapy. | At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days) |
| Composite Complete Response (CRc) rate after 1/2 treatment cycles |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | 310000 | China |
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| Active Comparator |
Participants received induction chemotherapy with daunorubicin and cytarabine. Patients achieving partial response (PR) with a reduction in bone marrow blasts >60% were allowed to receive one additional cycle of the same regimen. Patients who achieved complete response received consolidation therapy with lisaftoclax in combination with intermediate-dose cytarabine for 3 cycles. After completion of consolidation therapy, next-generation sequencing (NGS) was performed. Patients with minimal residual disease (MRD) negativity did not receive maintenance therapy, whereas patients with MRD positivity proceeded to maintenance therapy. Maintenance therapy consisted of lisaftoclax in combination with azacitidine, administered for up to 1 year or 10 cycles, whichever occurred first. |
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| Lisaftoclax+homoharringtonine+cytarabine+aclarubicin | Drug | Lisaftoclax (200 mg on D2, 400 mg on D3, and 600 mg qd on D4-8, orally) + homoharringtonine (2 mg/m², qd, intramuscular injection or iv infusion, D1-5) + cytarabine (100 mg/m², q12h, subcutaneous injection or iv infusion, D1-5) + aclarubicin (12 mg/m², maximum 20 mg, iv, D1-5). |
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| Daunorubicin+cytarabine | Drug | Daunorubicin (60 mg/m², iv, qd, D1-3) + cytarabine (100 mg/m², q12h, subcutaneous injection or iv infusion, D1-7). |
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| Lisaftoclax+cytarabine | Drug | Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles |
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| Lisaftoclax+azacitidine | Drug | Lisaftoclax (400 mg, orally, D1-7) + azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first. |
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defined as the proportion of patients achieving CRc after the first or second cycle of induction chemotherapy. |
| At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days) |
| Minimal residual disease (MRD) negativity rate after 1-2 cycles of induction chemotherapy | defined as the the proportion of patients with negative minimal residual disease (MRD) among patients who achieve complete remission after 1-2 cycles of induction chemotherapy | At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days) |
| 2-year overall survival rate (OS) | defined as the proportion of patients who were still alive from the time of randomization for the last patient until 24 months later | from randomization up to 2 years |
| 2-year relapse-free survival (RFS) rate | defined as the proportion of patients who achieved complete response (CR) or complete remission with incomplete hematologic recovery (CRi) and remained alive without disease relapse within 2 years after achieving response. | from the date of complete remission (CR/CRi) up to 2 years after achieving response |
| Safety and Tolerability | defined as the number of participants with adverse events and serious adverse events as assessed by NCI CTCAE v5.0 | up to 24 months |
| 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 |
|---|---|
| D060828 | Induction Chemotherapy |
| D058850 | Opiate Substitution Treatment |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D012074 | Remission Induction |
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