Interferon-α Maintenance in Favorable-Risk AML
Interferon-α as Maintenance Therapy for Favorable-Risk Acute Myeloid Leukemia: A Prospective, Single-Arm Study
Acute myeloid leukemia (AML) is a blood cancer with a substantial risk of relapse after initial treatment. Although patients with favorable-risk AML generally have better outcomes, relapse remains a major concern. Interferon-alpha (IFN-α) may help prevent relapse, but its effectiveness as maintenance therapy has not been confirmed in prospective studies.
This prospective, single-arm study aims to evaluate the efficacy and safety of IFN-α as maintenance therapy in patients with favorable-risk AML. Participants will receive IFN-α maintenance treatment and will be followed for disease relapse, survival, and treatment-related adverse events.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: Yuanjie Ding
- Número de telefone: 010-88325948
- E-mail: rmkyc@163.com
Estude backup de contato
- Nome: Fei-fei Tang
- Número de telefone: 86-13521893860
- E-mail: bjmugirl@163.com
Locais de estudo
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Beijing, China
- Recrutamento
- Peking University People's Hospital
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Contato:
- Fei-fei Tang
- Número de telefone: 86-13581671687
- E-mail: bjmugirl@163.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
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Age 18-70 years, inclusive.
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Newly diagnosed favorable-risk acute myeloid leukemia (AML) according to the 2022 European LeukemiaNet (ELN) risk classification.
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Achieved first complete remission (CR1) after 1-2 courses of standard chemotherapy.
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Completed 4-6 courses of consolidation chemotherapy, including at least 2 courses of high-dose cytarabine (HiDAC).
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Bone marrow examination at the end of consolidation therapy confirms continued CR1, with flow cytometric measurable residual disease (MRD) <0.1% and/or a >3-log reduction in molecular disease burden.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
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Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN), and total bilirubin ≤2 times ULN, based on laboratory tests performed within 2 weeks before enrollment.
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Renal function: serum creatinine ≤1.5 times ULN, based on laboratory tests performed within 2 weeks before enrollment.
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Exclusion Criteria:
- Acute promyelocytic leukemia (APL).
- Patients who strongly prefer transplantation, or who have an indication for transplantation but are unable to undergo transplantation.
- Uncontrolled active infection.
- Severe organ failure.
- Pregnancy.
- Unwillingness to receive interferon therapy.
- History of hyperthyroidism or hypothyroidism.
- Participation in another clinical study within 1 month before enrollment. -
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Peginterferon Alfa-2b Maintenance Therapy
Eligible patients with favorable-risk acute myeloid leukemia (AML) in first complete remission (CR1) after consolidation chemotherapy will receive peginterferon alfa-2b injection at a dose of 135 μg once weekly by subcutaneous injection for 6 months. Participants will be monitored for disease relapse, measurable residual disease (MRD), survival, and treatment-related adverse events, with follow-up for 2 years after enrollment. |
Pegylated interferon alfa-2b injection, administered at a dose of 135 μg once weekly by subcutaneous injection for 6 months as maintenance therapy in patients with favorable-risk acute myeloid leukemia (AML) in first complete remission (CR1) after consolidation chemotherapy. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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2-Year Cumulative Incidence of Relapse
Prazo: 2 years after enrollment
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The proportion of patients who experience disease relapse within 2 years after enrollment. Relapse is defined as bone marrow blasts ≥5%, detection of leukemic cells in peripheral blood, or extramedullary leukemia. |
2 years after enrollment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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2-Year Event-Free Survival (EFS)
Prazo: 2 years after enrollment
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Event-free survival is defined as the time from enrollment to the first occurrence of molecular progression, hematologic relapse, or death from any cause. |
2 years after enrollment
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2-Year Overall Survival (OS)
Prazo: 2 years after enrollment
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Overall survival is defined as the time from enrollment to death from any cause. Participants who are alive at the last follow-up will be censored. |
2 years after enrollment
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MRD Conversion Rate Among Patients With MRD-Positive Disease at Enrollment
Prazo: Up to 2 years after enrollment
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The proportion of patients with measurable residual disease (MRD)-positive status at enrollment who achieve MRD-negative status during follow-up, assessed by multiparameter flow cytometry and/or quantitative PCR. |
Up to 2 years after enrollment
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Number of Participants With Grade 3 or Higher Adverse Events
Prazo: During the 6-month maintenance treatment period
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The number of participants experiencing grade 3 or higher adverse events during peginterferon alfa-2b maintenance therapy, including hematologic and hepatic toxicities. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
During the 6-month maintenance treatment period
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Xiangyu Zhao, Peking University People's Hospital
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IFN-α in AML Maintenance
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