NCT02856997Unknown2 期
Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma: A Phase II Clinical Trial
Yuankai Shi0 个研究点目标入组 35 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 35
- 主要终点
- Objective remission rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Chidamide with ICE regimen in patients with relapsed/refractory Peripheral T Cell lymphoma.
详细描述
Efficacy of the combined regimen is evaluated primarily by objective remission rate, including complete remission, unverified complete remission and partial remission, also by duration of remission, progression free survival, and overall survival.
Safety is accessed by:
- The type, incidence, severity of incidents related to the use of the regimen.
- Laboratory abnormalities, including the type, incidence, severity, relationship with the use of the regimen.
- Incidence of level 3-4 incidents and laboratory abnormalities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Peripheral T Cell Lymphoma (PTCL) verified by histopathology/ cytology, according to WHO 2008 classification criteria, including: adult T cell lymphoma or leukemia (human T cell leukemia virus 1 positive); angioimmunoblastic t cell lymphoma; ALK positive anaplastic large cell lymphoma; ALK negative anaplastic large cell lymphoma; non-specified peripheral T cell lymphoma; extra-nodal NK/T cell lymphoma; bowl disease related T cell lymphoma; hepatosplenic T cell lymphoma; subcutaneous panniculitis-like T cell lymphoma; allergic mycosis fungoides.
- •There is at least 1 focus that could be evaluated both by histopathology and cytology (˃1.5cm) according to Cheson criteria.
- •The patients should have had at least 1 course of systemic treatment (including chemo-therapy, stem cell transplantation etc), but did not achieve remission or had relapse after remission.
- •Age18-75 years, male or female;
- •General condition should be ECOG 0-
- •Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥80 × 109/L, Hb ≥ 90g/L;
- •Expected survival ≥ 3 months;
- •No radiotherapy, chemotherapy, targeted therapy or hemopoietic stem cell transplantation received within 4 weeks prior to enrollment.
- •Willing to sign the written consent.
排除标准
- •Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures.
- •QTc elongation with clinical significance ( male˃ 450ms, female˃ 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment.
- •Patients who have received organ transplantation.
- •Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.
- •Patients with active hemorrhage.
- •Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
- •Patients with active infection, or with continuous fever within 14 days prior to enrollment.
- •Had major organ surgery within 6 weeks prior to enrollment.
- •Impaired liver function ( Total bilirubin ˃ 1.5 times of normal maximum, ALT/AST˃ 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST ˃ 5 times of normal maximum), impaired renal function (serum creatinin˃ 1.5 times of normal maximum).
- •Patients with mental disorders or those do not have the ability to consent.
- •Patients with drug abuse, long term alcoholism that may impact the results of the trial.
- •Non-appropriate patients for the trial according to the judgment of the investigators.
研究组 & 干预措施
Chidamide with ICE regimen
Experimental
Drugs:Chidamide and ICE regimen (ifosfamide, Mesna,Carboplatin and etoposide): Chidamide 20mg on d1,4,8,11;ifosfamide 1.2g/ m2，d1-4,ivg during 4 hours; Mesna 0.4g, 0,4,8 hours during Ifosfamide transfusion, ivg, d1-4; Carboplatin AUC=4, d2,ivg; etoposide 65mg/m 2, d1-4, ivg. 3 weeks as 1 course, for 6 courses.
if the effect is PR or better than PR, go to auto-stem cell transplantation, no further treatment with Chidamide is needed.
If the effect is PR or better than PR and no auto-stem cell transplantation available,Chidamide 20mg orally, twice every week, till the end of the trial.
干预措施: Chidamide with ICE regimen (Drug)
结局指标
主要结局
Objective remission rate
时间窗: through study completion, an average of 30 months
次要结局
- progress free survival(through study completion, an average of 30 months)
- overall survival(through study completion, an average of 30 months)
- Duration of remission(through study completion, an average of 30 months)
- blood platelet count(every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- vital signs(every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- white blood cell count(every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- blood Hb level(every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- Serum direct bilirubin level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- Serum glutamyltranspeptidase level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- red blood cell count(every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- Serum alanine aminotransferase level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- Serum aspartate transaminase level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- Serum total bilirubin level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- Serum indirect bilirubin level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- Serum creatinin level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- blood LDH level(every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- QTc from ECG(every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- Serum albumin level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- Serum ureal nitrogen level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- fasting blood glucose level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- blood electrolytes level（K+, Na+，Cl-，Ca2+，Mg2+）(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
研究者
Yuankai Shi
Dr.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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