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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 OS rate of the LDA, LHAA, and LA regimens in newly diagnosed patients with intermediate- and high-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 therapy with lisaftoclax, daunorubicin, and cytarabine. Patients with partial response (PR) or >60% reduction in bone marrow blasts were allowed to receive one additional induction cycle. Patients achieving complete response received consolidation therapy with lisaftoclax and intermediate-dose cytarabine for 3 cycles. For maintenance therapy, patients were classified as post-transplant or non-transplant. Post-transplant patients were randomized 1:1 to receive either lisaftoclax plus azacitidine or azacitidine alone. Non-transplant patients received lisaftoclax in combination with azacitidine. Maintenance therapy was administered for up to 1 year or 10 cycles, whichever occurred first, or until the occurrence of grade ≥4 hematologic toxicity. |
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| Arm B: Lisaftoclax+homoharringtonine+cytarabine+aclarubicin | Experimental | Participants received induction therapy with lisaftoclax, homoharringtonine, cytarabine, and aclarubicin. Patients with partial response (PR) or >60% reduction in bone marrow blasts were allowed to receive one additional induction cycle. Patients achieving complete response received consolidation therapy with lisaftoclax and intermediate-dose cytarabine for 3 cycles. For maintenance therapy, patients were stratified according to transplantation status (post-transplant or non-transplant). Post-transplant patients were randomized 1:1 to receive either combination therapy or azacitidine monotherapy. Non-transplant patients received combination maintenance therapy. All maintenance therapies were administered for up to 1 year or 10 cycles, whichever occurred first, or until the occurrence of grade ≥4 hematologic toxicity, and were interrupted until recovery to grade ≤2. |
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| 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 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 |
| 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 of 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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| Arm C:Lisaftoclax+ azacitidine |
| Experimental |
Participants received induction therapy with lisaftoclax in combination with azacitidine. Patients with partial response (PR) or >60% reduction in bone marrow blasts were allowed to receive one additional induction cycle. Patients achieving complete response received consolidation therapy with lisaftoclax and intermediate-dose cytarabine for 3 cycles. For maintenance therapy, patients were stratified according to transplantation status (post-transplant or non-transplant). Post-transplant patients were randomized 1:1 to receive either combination therapy or azacitidine monotherapy. Non-transplant patients received combination maintenance therapy. All maintenance therapies were administered for up to 1 year or 10 cycles, whichever occurred first, or until the occurrence of grade ≥4 hematologic toxicity, and were interrupted until recovery to grade ≤2. |
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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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| Lisaftoclax+azacitidine | Drug | Lisaftoclax (200 mg, orally, D1; 400 mg, orally, D2; 600 mg, orally, qd, D3-28) + azacitidine (75 mg/m², 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 or azacitidine | Drug | Post-transplant maintenance therapy: patients were randomized 1:1 to receive either combination therapy or azacitidine monotherapy. The combination regimen consisted of lisaftoclax (400 mg, orally, D1-7) in combination with azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first. Azacitidine monotherapy consisted of azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first. Non-transplant maintenance therapy: lisaftoclax (400 mg, orally, D1-7) in combination with 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 of 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 of induction chemotherapy (each cycle is 28 days) |
| 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 |
| 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 |
| D001374 | Azacitidine |
| D058850 | Opiate Substitution Treatment |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D012074 | Remission Induction |
| 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 |
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