EUCTR2020-003986-20-DE进行中（未招募）1 期
A Phase II, Open-Label, Multicenter Study of Orally Administered CA-4948 for the Treatment of Anemia in Patients with Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) - LUCAS
eipzig University0 个研究点目标入组 84 人开始时间: 2021年3月15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
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- MDS OR MDS/MPN including MDS/MPN-RS-T, MDS/MPNu, aCML or CMML
- •- 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
- •- Defined transfusion strategy
- •- No available option of an approved MDS therapy and classification of prior erythropoiesis-stimulating agent (ESA) treatment as follows:
- •+ Cohort A: ESA exposed (and refractory or intolerant);
- •+ Cohort B: ESA naive AND serum erythropoietin level >200 U/L
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Compliance with major study procedures
- •1. Inability to swallow and retain oral medications (> 10 pills)
- •2. Patient does not accept bone marrow sampling
- •3. Patient does not accept up to weekly peripheral blood sampling
- •4. Eastern Cooperative Oncology Group (ECOG) Performance Status of =3
- •5. Inacceptable organ function:
- •a. Serum creatinine >2 × ULN or calculated creatinine clearance < 30 ml/min
- •b. Aspartate aminotransferase (AST) > 2 × ULN OR alanine aminotransferase (ALT) > 2 × ULN
- •c. Total bilirubin >2 × ULN
- •i. exception >3 × ULN in patients with documented Gilbert’s syndrome
- •Interfering treatments
- •6. Prior treatment with azacitidine (injectable or oral) or decitabine.
- •7. The patient medically requires treatment with the following drugs that are forbidden during the trial or was exposed to one of these 14 days before registration:
- •a) Erythropoiesis stimulating agent (ESA) or luspatercept,
- •b) Granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony stimulating factor (GM-CSF)
- •c) Lenalidomide
- •d) Another investigational drug or device, or approved therapy for investigational use
- •8. Iron chelation therapy
- •9. Major surgery within 28 days prior to registration.
- •Concomitant diseases
- •10. Known human immunodeficiency virus (HIV) infection
- •11. Active infectious hepatitis (Type B (HBV) or Type C (HCV)
- •12. Hepatitis virus detectable within 6 months before registration in patients with a history of hepatitis
- •13. History of other invasive malignancy, unless definitively treated with curative intent, provided it is deemed to be at low risk for recurrence by the treating physician
- •14. Presence of an acute or chronic toxicity resulting from prior anti-cancer therapy that has not resolved to Grade =1 (except anemia and alopecia), as determined by NCI CTCAE v 5.0
- •15. Known allergy or hypersensitivity to any component of the formulation of CA-4948 used in this study
- •16. Severe cardiovascular disease
- •Formal requirements
- •17. Positive serum pregnancy test in women of childbearing potential
- •18. Women of childbearing potential and men who partner with a woman of childbearing potential unwilling to use highly effective contraceptive methods for the duration of the study and for 90 days after the last dose of CA-4948
- •19. Age under 18 years at registration
- •20. Inability to provide written informed consent (Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial)
- •21. Simultaneous participation in another interventional clinical trial or participation in any clinical trial involving administration of an investigational medicinal product within 28 days prior registration
研究者
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