KCT0000737招募中未知
A Phase 2 Study of KOMINOX (KML001) for Refractory or Recurrent non-Hodgkin's lymphoma
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- Komipharm
- 入组人数
- 51
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
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1)Non-Hodgkin’s lymphoma confirmed histologically or cytologically
- •2)Patients who did not achieve a complete remission with second-line chemotherapy or who relapse after chemotherapy. (However, patients who is not the subject of the secondary chemotherapy after primary chemotherapy can participate)
- •3)Patients who is unsuited or failed to high dose chemotherapy or stem cell transplantation
- •4)Age over 20 years
- •5)ECOG performance status = 2
- •6)At least one unidimensionally measurable lesion
- •7)Adequate hematological, hepatic, and renal functions were required :
- •- ANC =1500/mm3, Platelets =75,000/mm3
- •- Nomal serum creatinine range or CCr =60ml/min (by Cockcroft-Gault equation)
- •- Normal serum electrolytes (including calcium, magnesium, phosphorus, potassium)
- •calcium: 8.3~10.5mg/dl, magnesium: 1.58~3.0mg/dl,
- •phosphorus: 2.4~4.5mg/dl, potassium: 3.3~5.5mmol/L
- •- Serum bilirubin <2? upper normal limit (ULN), AST/ALT <2.5?ULN, ALP <5?ULN
- •8)Corrected QT interval < 0.48 sec
- •9)Informed consent given in written form after being provided with detailed information about the nature, risks and scope of the clinical trial as well as the expected desirable and adverse effects of the drug
排除标准
- •1)Central nervous system involvement or testicular involvement of non-Hodgkin’s lymphoma
- •2)History of major gastrointestinal surgery or pathology likely to influence absorption of the study medication
- •3)Patients previously treated with arsenic compounds
- •4)Active infection requiring treatment with parenteral antibiotics within 7 day) (Exception : topical antibiotics)
- •5)Any concomitant other cancer type (exception: basal cell carcinoma or in situ uterine cervical cancer or papillary thyroid cancer patients within 5 years before participation in clinical)
- •6)=Grade 2 peripheral neuropathy patients
- •7)Known history of increased risk for torsade de pointes (TdP) like hypokalemia, family history of Long-QT syndrome
- •8)Myocardial infarction within 6 months before participation in this clinical study, New York Heart Association criteria (NYHA) class 3 or 4 of congestive heart failure, uncontrolled hypertension (diastolic BP >100 or uncontrolled hypertention and unstable angina of systolic >180 or cardiomyopathy and arrhythmia of ejection fraction)
- •9)Pregnant or lactating women
- •10)Patients who don’t agree on contraception.
- •11)Patients with uncontrolled chronic diseases (e.g. chronic hepatitis, Chronic kidney disease, uncontrolled diabetes)
- •12)Participation in another clinical trials
- •13)Known hypersensitivity to any of the active or inactive components of the final product
- •14)HIV positive patients
- •15)Patients who take drugs that have been reported to cause the QT prolongation and/or torsades de pointes (e.g. Indapamide, Dobutamine, Amiodarone, Ibutilide etc.)
研究者
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