Selinexor Combined With Azacitidine Therapy in High-Risk Myeloid Neoplasms Patients

Официальное название

Efficacy and Safety of Selinexor Combined With Azacitidine as Maintenance Therapy in High-Risk Myeloid Neoplasms Patients Post-Transplantation: A Single-Center, Single-Arm, Explorato

Обзор

Efficacy and Safety of Selinexor Combined with Azacitidine as Maintenance Therapy in High-Risk Myeloid Neoplasms Patients Post-Transplantation: A Single-Center, Single-Arm, Exploratory Study

Подробное описание

Treatment period: From the time of transplantation, after screening by inclusion and exclusion criteria, patients who meet the criteria are enrolled and given maintenance therapy with Selinexor in combination with azacitidine (Selinexor: 40 mg/weekly, administered on D1; azacitidine: 50 mg/m2\*5d; every 28 days for a cycle of treatment, for at least one year of medication, or until progression of the disease, or until the development of intolerable toxicity, whichever comes first)

Вмешательства

• Препарат Selinexor
  maintenance therapy with Selinexor combined with Azacitidine in patients with high-risk myeloid neoplasms after transplantation

Первичные конечные точки

• 2-year recurrence free survival rate (RFS) [Срок оценки: 2 years]

Вторичные конечные точки (4)

• 2-year non-relapse mortality rate (NRM) [Срок оценки: 2 years]
• 2-year survival rate (OS) [Срок оценки: 2 years]
• Median overall survival (OS) [Срок оценки: 2 years]
• Cumulative incidence of acute graft-versus-host disease (GVHD) [Срок оценки: 2 years]

Критерии участия

Критерии включения

with pre-transplant MRD-positive AML, i.e., patients who meet one of the following criteria:

• Age≥ 16 years old; any gender;
• High-risk MDS (IPSS-R or/and IPSS-M high-risk and above);
• High relapse risk AML, including relapsed refractory AML and patients with pre-transplant MRD-positive AML, i.e., patients who meet one of the following criteria:

(1)Refractory AML is defined as meeting one of the following conditions

• Primary cases that have failed to respond to 2 courses of standard regimen chemotherapy;
• CR was followed by consolidation and intensive treatment with no recurrence within 12 months;
• It recurred 12 months later, but conventional chemotherapy was ineffective;
• 2 or more relapses;
• Extramedullary leukemia persists. (2)Relapsed AML i.e., re-initialization of leukemic cells in the peripheral blood after complete remission (CR) or bone marrow primitive cells >0.050 (except for other reasons such as bone marrow reconstitution after consolidation chemotherapy) or extramedullary infiltration of leukemic cells.

(3)Positive pre-transplant MRD, i.e., one of the following conditions is met:

• Proportion of abnormal myeloid cells >0.01% by pre-transplant flow assay;
• Positive pre-transplantation molecular biology-related tests. (4)AML with poor prognosis (according to the Chinese Guidelines for the Diagnosis and Treatment of Adult Acute Myeloid Leukemia (Non-Acute Promyelocytic Leukemia) 2023 Edition) 4.Meets WHO diagnostic criteria for staging CMML; 5.MDS or CMML transforms AML.

Критерии исключения

Patients with any of the following are not eligible for enrollment in this study:

• Patients who relapsed within 3 months of transplantation or during maintenance therapy, including hematologic, molecular genetic, cytogenetic relapses, and extramedullary relapses.
• Known positive serology for HIV or active hepatitis B virus (HBV) and hepatitis C virus (HCV);
• Requirements for mental illness or other conditions that preclude cooperation with study treatment and monitoring;
• Patients who are pregnant or who are unable to use appropriate contraception during treatment;
• Suspected hypersensitivity to the experimental drug or any of its excipients;
• Active heart disease, defined as one or more of the following:

（1）History of uncontrolled or symptomatic angina; （2）Myocardial infarction less than 6 months from study entry; （3）History of tardive dyskinesia requiring medication or clinically significant symptoms; （4）Uncontrolled or symptomatic congestive heart failure (> NYHA class 2) （5）Ejection fraction is below the lower limit of the normal range. 7. Those deemed unsuitable for enrollment by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, — Тяньцзинь

Идентификаторы

NCT: NCT06900088 · IIT2024099

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗