CTIS2024-515886-33-00进行中（未招募）1 期
A Phase II, Single-Arm, Open-Label Study to Assess the Efficacy and Safety of Canakinumab for the Treatment of Anemia in Patients with IPSS-RVery Low, Low, or Intermediate Risk Myelodysplastic Syndromes or MDS/MPNCANFIRE Trial - CANFIRE
niversitaet Leipzig0 个研究点目标入组 11 人开始时间: 2024年6月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Cytomorphology based confirmed diagnosis of lower-risk MDS or MDS/MPN including MDS/MPN-RS-T, MDS/MPNu, aCML or CMML (as per the World Health Organization [WHO] 2016 classification), IPSS-R up to 3.5: very low/low/intermediate risk disease (MDS); MDS/MPN < 10% bone marrow blasts; CPSS-Score low/intermediate for CMML, Symptomatic anemia (based on complete Hb time course and transfusion history), Relapsed / refractory / intolerant / ineligible (sEPO = 200 U/L) to ESA treatment, Age = 18 years, Written informed consent
排除标准
- •Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding, Active second malignancy, Prior or concomitant treatment with anticancer medications or disease modifying agents, Previously treated with canakinumab, Prior allogeneic or autologous stem cell transplant, Known history of diagnosis of AML, Severe neutropenia (ANC ? 0.5 Gpt/L), Severe thrombocytopenia (PLT <30 Gpt/L), Serum creatinine > 1.5x ULN OR measured or calculated creatinine clearance < 40 ml/min, AST or ALT = 3.0 x ULN, ECOG > 2, Total bilirubin = 2.0 x
研究者
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