Comparing the Efficacy of the LDA, LHAA, and DA Regimens in Young Adults With Low-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy
A Multicenter, Prospective, Randomized Controlled Clinical Study Comparing the Efficacy of the LDA, LHAA, and DA Regimens in Young Adults With Low-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Locais de estudo
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- The First Affiliated Hospital of Zhejiang University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Newly diagnosed acute myeloid leukemia (AML) confirmed according to the World Health Organization (WHO) classification;
- Classified as intermediate- or adverse-risk AML based on the European LeukemiaNet (ELN) 2022 genetic risk stratification;
- Age 18-65 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Adequate hepatic and renal function: total bilirubin ≤2 mg/dL (35 μmol/L); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2× the upper limit of normal; serum creatinine ≤177 μmol/L;
- Normal cardiac function, defined as left ventricular ejection fraction (LVEF) >50%;
- Life expectancy ≥3 months;
- Signed written informed consent by the patient or their legally authorized representative prior to study enrollment.
Exclusion Criteria:
- Acute promyelocytic leukemia;
- Central nervous system involvement by leukemia;
- History of other malignancies within the past 5 years;
- Positive for human immunodeficiency virus (HIV);
- Presence of any other serious medical condition that may limit study participation, including advanced infections, uncontrolled diabetes mellitus, severe cardiac insufficiency, or angina;
- Ineligible for intensive chemotherapy due to poor general condition;
- Pregnant or breastfeeding women;
- Inability to understand or comply with the study protocol;
- Inability to take oral medication or presence of malabsorption syndrome;
- Prior treatment with B-cell lymphoma 2 (BCL-2) inhibitors or hypomethylating agents, or current participation in any other investigational drug study;
- Inability or unwillingness to provide written informed consent.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Arm A: Lisaftoclax+Daunorubicin+Cytarabine
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. |
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).
Outros nomes:
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
Outros nomes:
Lisaftoclax (400 mg, orally, D1-7) + azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first.
Outros nomes:
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Experimental: Arm B: Lisaftoclax+homoharringtonine+cytarabine+aclarubicin
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. |
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
Outros nomes:
Lisaftoclax (400 mg, orally, D1-7) + azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first.
Outros nomes:
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).
Outros nomes:
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Comparador Ativo: Arm C: Daunorubicin+cytarabine
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. |
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
Outros nomes:
Lisaftoclax (400 mg, orally, D1-7) + azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first.
Outros nomes:
Daunorubicin (60 mg/m², iv, qd, D1-3) + cytarabine (100 mg/m², q12h, subcutaneous injection or iv infusion, D1-7).
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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2-year event-free survival (EFS) rate
Prazo: from randomization up to 2 years after randomization
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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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Complete Response (CR) rate after 1/2 treatment cycles
Prazo: At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
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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
Prazo: At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
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defined as the proportion of patients achieving CRc after the first or second cycle of induction chemotherapy.
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At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
|
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Minimal residual disease (MRD) negativity rate after 1-2 cycles of induction chemotherapy
Prazo: At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
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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
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At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
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2-year overall survival rate (OS)
Prazo: from randomization up to 2 years
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defined as the proportion of patients who were still alive from the time of randomization for the last patient until 24 months later
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from randomization up to 2 years
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2-year relapse-free survival (RFS) rate
Prazo: from the date of complete remission (CR/CRi) up to 2 years after achieving response
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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.
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from the date of complete remission (CR/CRi) up to 2 years after achieving response
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Safety and Tolerability
Prazo: up to 24 months
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defined as the number of participants with adverse events and serious adverse events as assessed by NCI CTCAE v5.0
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up to 24 months
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CN-ZY-26-01
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