KCT0002421已完成未知
Phase 1 study to evaluate safety and pharmacokinetic property of DNP001 in patients with JL1 postive acute leukemia or myelodysplastic syndrome
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. =19 years
- •2. Diagnosed with JL1-positive* acute leukemia, acute-stage chronic leukemia or myelodysplastic syndrome on tissue biopsy and showed recurrence to or non-responsive to standard therapy, or patients with =65 years where high-intensive standard chemotherapy is not adequate (*JL-1-positive is determine as ?10% of JL1 positive cells unon analysis by flow cytometry)
- •3. Patients who did not have (or recoveredfrom its side effects) opration, radiation therapy, Treitinoin treatment, arsenic trioxide treatment, immunotherapy, methylation inhibitor therapy or chemotherapy within 4 weeks period prior to participating in the study. Except administration of hydroxyurea is permitted but has to be stopped 24 hr prior to the administration of study drug
- •4. Patients with = 2 Eastern Cooperative Oncology Group (ECOG) performance status
- •5. Patients with life expectancy of ?3 months
- •6. Patients with the following test results prior to treatment
- •1) Total bilirubin = 1.5 x Upper Limit of Normal (Except in the case of Gilbert’s syndrome and when the indirect bilirubinis increased)
- •2) AST & ALT = 3 x Upper Limit of Normal (With the exception of when patient was diagnosed with liver invasion of leukemia)
- •3) Creatinine clearance (CrCl) = 30 mL/min (using Cockcroft and Gault’s formula)
- •7. Patients with their written consent form filled out either by the patient or his/her lawful representative, and can abide to the study requirements prior to the start of clinical trial
排除标准
- •1. Patients with scheduled allogeneic hematopoietic stem cell transplantation during trial period
- •2. Patients hypersensitive to the components of study drug
- •3. Patients with active invasion of leukemia to leptomeningeal or central nervous system (CNS)
- •4. Patients with recent history of major surgery
- •5. Patients with progression of complication with surgery or wound recovery
- •6. Patients with hemorrhaging tendency due to reasons other than leukemia or who are being treated with anti-coagulatory treatment
- •7. Patients with major complicating disorder or major non-tumor hepatic disorder (eg, cirrhosis, active chronic hepatitis), or who experienced myocardiac infarction (MI) or unstable angina within 6 months period prior to start of trial, or who has clinically significant heart disease
- •8. Patients with prior history of major neurological or psychological disorder that could influencepatient adgerencerelated to the evaluation of trial protocol
- •9. Patients who has uncontrollable infection under progression
- •10. HIV (human immunodeficiency virus)positive patients
- •11. Women who are pregnant or breastfeeding, or fertile men or women who did ont consent to effective contraceptive method during or after the treatment up to 6 months
- •12. Patients who were administered with biologics including hematopoietic growth factor within 1 week period prior to start of trial
- •13. Patients with evidence of rapid proliferating disease treated with other study drug within 5 times the half-life period prior to be selected for trial, or if half-life is not known within 30 days of treatment
- •14. Patients with other relate disease or adverse clinical symptom who are deemed inappropriate to participate in the clinical study by the investigator
研究者
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