KCT0008729尚未招募Unknown
Evaluation of treatment efficacy according to risk group in relapsed childhood acute lymphoblastic leukemia
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 90
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
- 12(Month) 至 22(Year)（—）
- 性别
- All
入选标准
- •1. Patients >= 1 year and < 22 years of age at the time of relapse will be eligible
- •2. Participants must have a histologic diagnosis of acute lymphoblastic leukemia:
- •B-ALL: Precursor B-cell acute lymphoblastic leukemia
- •T-ALL: Precursor T-cell acute lymphoblastic leukemia
- •3. 1st recurred acute lymphoblastic leukemia patients, recurred parts including marrow. Enrolling patients with combined extra medullary relapse including bone marrow is acceptable. (No limits for extra medullary site) Additionally, subjects whose blast cells in bone marrow are less than 5% (ALL whether type M2 or M3 must be definite)
- •4. Patients who have never received allogeneic stem cell transplant
- •5. Patients who have never received blinatumomab before
- •6. Adequate Renal Function
- •-A serum creatinine based on age/gender as follows:
- •1 to < 2 years - Male (0.6) Female (0.6)
- •2 to < 6 years - Male (0.8) Female (0.8)
- •6 to < 10 years - Male (1) Female (1)
- •10 to < 13 years - Male (1.2) Female (1.2)
- •13 to < 16 years - Male (1.5) Female (1.4)
- •= 16 years - Male (1.7) Female (1.4)
- •7. Adequate Liver Function defined as a direct bilirubin < 3.0 mg/dL
- •8. Adequate Cardiac Function defined as
- •Shortening fraction of = 27% by echocardiogram, or
- •Ejection fraction of = 50% by echocardiogram
- •9. Lansky (age < 16 years) or Karnofsky (age = 16 years) performance status = 60% at screening
- •10. Patients with a life expectancy of 1 or more year
- •11. Patients who are expected to comply with all required study procedures and follow the study protocol in the opinion of the investigator
- •12. Signed written informed consent and assent forms must be obtained prior to any study procedures
排除标准
- •1. Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia
- •2. Patients with Philadelphia chromosome positive (Ph+) ALL
- •3. Patients with CD19-negative recurrent progenitor B-cell acute lymphoblastic leukemia (non-expression of CD19 in peripheral blood or bone marrow by flow cytometry) are not eligible for administration of Blinatumomab
- •4. In case of relapsed within 1 month after the end of induction with the same 4-drug therapy used in this study
- •5. Patients with mixed phenotype leukemia
- •6. Patients with genetic syndrome: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome bone marrow failure syndrome
- •7. Patients with HIV
- •8. Female patients who are not proved as infertile or pregnant (Evidence of infertility: History taking of possibilities of pregnancy or urine human chorionic gonadotrophin test negative, amenorrhea more than a year, Natural or artificial (Ex.hormone therapy) menopause status more than a year, surgical sterilization(Ex.Hysterectomy or ovariotomy etc)
- •9. Currently receiving treatment in another investigational drug study or clinical trial
- •10. Evidence of unstable conditions that would pose a risk to subject safety or interfere with the patients' compliance
- •11. Patients with clinically relevant central nervous system (CNS) pathology or active CNS involvement including: unstable epilepsy, uncontrolled seizure, paralysis, aphasia, history of severe brain injury, cerebellar disease, organic brain syndrome, psychosis, coordination/movement disorder
- •12. Known hypersensitivity to drugs or components to be administered: Idarubicin, Etoposide, Ifosfamide, Cytarabine, Vincristine, Mercaptopurine, Blinatumomab
研究者
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