The Efficacy and Safety of Chidamide Combined With VDDT Regimen（Vinorelbine，Liposomal Doxorubicin，Dexamethasone and Thalidomide） in Relapse and Refractory Patients With Diffuse Large B Cell Lymphoma
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- objective response rate
研究概览
简要总结
This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide combined with VDDT(vinorelbine，liposomal doxorubicin，dexamethasone and thalidomide) in relapsed and refractory patients with diffuse large B-cell lymphoma(DLBCL).
详细描述
There are one third of diffuse large B-cell Lymphoma patients suffering relapse and refractory, which are the major cause of death among these patients. Vinorelbine，liposomal doxorubicin，mitoxantrone, dexamethasone and thalidomide have been used in the therapy of patients who failed with Second-line treatments in our center. This regimen is well tolerated but the effect needs to be improved. Chidamide，a histone deacetylase inhibitor has been approved for the treatment of refractory T-cell lymphoma in China. The goal is to assess the efficacy and safety of chidamide combined with VDDT（vinorelbine，liposomal doxorubicin，dexamethasone and thalidomide） in relapse and refractory patients with diffuse large B-cell Lymphoma.
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
- •Diagnosed as diffuse large B-cell Lymphoma based on the 2008 WHO classification of tumors of haematopoietic and lymphoid tissues
- •Failed with second-line therapy
- •Having at least one measurable lesions
- •Age between 18 to 75 years old
- •World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-1
- •Neutrophils more than 1.5*10^9/L; Platelets more than 90*10^9/L Hemoglobin: more than 90g/L.
- •Life expectancy no less than 3 months
- •No receiving chemotherapy in 4 weeks before enrollment
- •Agreeing to sign the written informed consents
排除标准
- •Pregnant ，lactating and patients at reproductive age who refuse to practice contraception
- •QTc prolonging >450ms，ventricular tachycardia，atrial fibrillation，cardiac conduction block， myocardial infarction in less than 1 year， congestive heart failure，coronary heart disease which needs medication.
- •Organ transplant recipients
- •Active bleeding
- •Thrombus，embolism，cerebral hemorrhage，cerebral infarction
- •Important organ operation in less than 6 weeks
- •Abnormal liver function（Note：total bilirubin >1.5 times the upper limit of normal，AST or ALT >2.5 times the upper limit of normal （Note：5 times the upper limit of normal for patients with liver involvement）），abnormal renal function（Note：serum creatinine >1.5 times the upper limit of normal），fluid and electrolyte disorders
- •Mental illness or unable to sign the informed consent
- •Drug addiction history or alcoholism which may interfere the experimental results.
- •Researchers determine unsuited to participate in this trial
- •Known allergy to any kind of study drugs
研究组 & 干预措施
Chidamide combined with VDDT regimen
Chidamide 30mg，Oral twice a week with an interval of no less than 3 days combined with regimen：VDDT（Vinorelbine，Liposomal doxorubicin or mitoxantrone ，Dexamethasone and Thalidomide）：repeated every 14 days ，up to 12 cycles
干预措施: Chidamide (Drug)
Chidamide combined with VDDT regimen
Chidamide 30mg，Oral twice a week with an interval of no less than 3 days combined with regimen：VDDT（Vinorelbine，Liposomal doxorubicin or mitoxantrone ，Dexamethasone and Thalidomide）：repeated every 14 days ，up to 12 cycles
干预措施: Vinorelbine (Drug)
Chidamide combined with VDDT regimen
Chidamide 30mg，Oral twice a week with an interval of no less than 3 days combined with regimen：VDDT（Vinorelbine，Liposomal doxorubicin or mitoxantrone ，Dexamethasone and Thalidomide）：repeated every 14 days ，up to 12 cycles
干预措施: Liposomal Doxorubicin or mitoxantrone (Drug)
Chidamide combined with VDDT regimen
Chidamide 30mg，Oral twice a week with an interval of no less than 3 days combined with regimen：VDDT（Vinorelbine，Liposomal doxorubicin or mitoxantrone ，Dexamethasone and Thalidomide）：repeated every 14 days ，up to 12 cycles
干预措施: Dexamethasone (Drug)
Chidamide combined with VDDT regimen
Chidamide 30mg，Oral twice a week with an interval of no less than 3 days combined with regimen：VDDT（Vinorelbine，Liposomal doxorubicin or mitoxantrone ，Dexamethasone and Thalidomide）：repeated every 14 days ，up to 12 cycles
干预措施: Thalidomide (Drug)
结局指标
主要结局
objective response rate
时间窗: every 8 weeks until 1 year after last patient's enrollment
the total proportion of patients with complete response（CR or CRu）and partial response（PR）
adverse events
时间窗: from the date of first cycle of treatment to 1 year after last patient's enrollment
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
incidence and relationship with study drugs of grade 3-4 adverse events and abnormal laboratory examinations
时间窗: from the date of first cycle of treatment to 1 year after last patient's enrollment
the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03) and abnormal laboratory examinations
abnormal laboratory examinations
时间窗: from the date of first enrollment to 1 year after last patient's enrollment
includes type, incidence, relationship with treatment and severity of abnormal laboratory examinations.
次要结局
- duration of response(from the day of first documented response to first documented progression or death，up to 1 year after last patient's enrollment)
- progression-free survival(from the day of treatment to the date of first documented progression，up to 1 year after last patient's enrollment)
研究者
Yanyan Liu
director
Henan Cancer Hospital