NCT06664970Enrolling By Invitation2 期
Prospective, Multicenter Study on the Treatment of Myelodysplastic Neoplasms (MDS)/Myeloproliferative Neoplasms (MPN) Overlap Syndrome With Azacitidine or Ruxolitinib Combined With Selinexor
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- ORR at 6 months of treatment
研究概览
简要总结
This study is a prospective, multicenter, open label cohort study involving MDS/MPN patients. The enrolled patients have symptoms that require treatment, which are classified according to their clinical conditions as follows: those with MDS as the main manifestation are treated with Azacitidine combined with Selinexor; For those with MPN as the main manifestation, treatment with Selinexor combined with Ruxolitinib is used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the diagnostic criteria of MDS/MPN (WHO 2022 edition)
- •Age ≥ 18 years old;
- •There are indications that require treatment, such as symptomatic anemia, decreased blood cells, splenomegaly, and constitutional symptoms;
- •ECOG score 0-2;
- •No stem cell transplantation plan within 6 months;
- •Liver function: Within 21 days before the start of treatment, total bilirubin<2 times the upper limit of normal (ULN), alanine aminotransferase (ALT)<2.5 times ULN;
- •Renal function: Within 21 days before the start of treatment, creatinine clearance rate ≥ 30 mL/min, calculated using Cockcroft and Gault formulas;
- •Patients receiving erythropoietin therapy or rituximab must be at a stable dosage and have stable transfusion therapy or hemoglobin levels within 8 weeks prior to entering the study.
- •Female patients with fertility must agree to the use of dual contraception methods and have a negative serum pregnancy test during screening. Male patients who have sexual intercourse with women with fertility must use effective barrier contraception methods.
- •Those who meet the requirements of the ethics committee and sign the informed consent form; Willing and able to comply with clinical visit and research related procedures.
排除标准
- •Those who have undergone major surgery within 4 weeks before the start of treatment,
- •those with severe liver and kidney dysfunction;
- •Patients who have undergone splenectomy in the past;
- •Patients with unstable cardiovascular function: symptomatic cardiac ischemia, uncontrolled significant conduction abnormalities, congestive heart failure (CHF) with NYHA functional class ≥ 3 or myocardial infarction within 6 months, unstable angina, unstable arrhythmia;
- •Uncontrolled active infections require systemic use of antibiotics, antiviral drugs, or antifungal drugs within one week prior to the first administration; Allow the use of prophylactic antibiotics.
- •Known active hepatitis A, B, or C infection; Or known to be positive for HCV RNA or HBsAg (HBV surface antigen); Known HIV seropositivity;
- •Patients with obvious gastrointestinal lesions or obstruction, or uncontrolled vomiting or diarrhea.
- •At baseline, peripheral neuropathy was ≥ grade 2 (within 21 days before the first day of the first cycle).
- •History of epileptic seizures, movement disorders, or cerebrovascular accidents (within 1 year before the first day of the first cycle)
- •Evidence of AML (≥ 20% of primitive cells in bone marrow or peripheral blood) according to WHO definition
- •Patients with other active malignant tumors
- •Pregnant and lactating women;
- •Fertility capable women or men who are unwilling to take effective contraceptive measures before the first dose/treatment, during the study period, and for at least 6 months after the last dose;
- •Patients without autonomous behavioral ability, such as psychiatric patients; Other situations deemed unsuitable for inclusion by researchers.
研究组 & 干预措施
Azacitidine or Ruxolitinib combined with Selinexor
Experimental
Azacitidine or Ruxolitinib combined with Selinexor
干预措施: Azacitidine or Ruxolitinib combined with Selinexor (Drug)
结局指标
主要结局
ORR at 6 months of treatment
时间窗: 6 months
ORR at 6 months of treatment
次要结局
未报告次要终点
研究者
Bing Han
PekingUMCH
Peking Union Medical College Hospital
研究点 (1)
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