NL-OMON40223招募中2 期
Phase 1-2 Safety and Efficacy Study of DACOGEN in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia. - DACOGE
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 3
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
- 2 至 17（—）
入选标准
- •- Histological diagnosis of acute myeloid leukemia (AML) according to the World Health Organization (WHO) classification
- •- Patient has a diagnosis of AML which has relapsed or is refractory to standard of care and no curative therapy exists
- •- Karnofsky or Lansky score of at least 50
- •- Must be recovered from acute toxicity of any prior treatment
- •- Must have adequate organ function according to protocol-defined criteria
- •- Agrees to protocol-defined use of effective contraception
- •- Female patients of childbearing potential must have a negative serum or urine pregnancy test at Day 1 of Cycle 1
- •- Female patients must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction
- •- Male patients must not donate sperm during the study and for 3 months after receiving the last dose of study drug.
排除标准
- •- Prior treatment with decitabine or azacitidine
- •- Acute promyelocytic leukemia (M3 subtype in the French-American-British [FAB] classification system)
- •- Symptomatic central nervous system involvement of acute myeloid leukemia (AML)
- •- AML with associated congenital syndromes such as Down syndrome, Fanconi anemia, Bloom syndrome, Kostmann syndrome or Diamond-Blackfan anemia, or bone marrow failure associated with inherited syndromes
- •- White blood cell count greater than 40,000 cells/mL
- •- Known allergies, hypersensitivity, or intolerance to decitabine or cytarabine or their excipients
- •- Contraindications to the use of cytarabine per local prescribing information or prior adverse reactions to cytarabine which would prevent further use
- •- Subject is currently enrolled in an interventional investigational study
- •- Female who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study drug (however, the period after which it becomes safe to become pregnant after the last dose of treatment is not known)
- •- Male who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug
- •- Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments
- •- Subject has any social or medical condition that in the investigator*s opinion renders the participant unfit for study participation
- •- subject has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease
- •- Subject has a history of human immunodeficiency virus (HIV) antibody positive
研究者
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