Chidamide Combined With Cladribine/Gemcitabine/Busulfan (ChiCGB) With Autologous Stem-Cell Transplantation in Relapsed and Refractory Diffuse Large B Cell Lymphoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 93
- 试验地点
- 18
- 主要终点
- Event free survival
研究概览
简要总结
The goal of this clinical research study is to evaluate effectiveness and safety of ChiCGB regimen( chidamide, cladribine, gemcitabine and busulfan).
Busulfan are designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die.
Gemcitabine and cladribine are designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may help to increase the effect of busulfan on cancer cells by not allowing these cells to repair the DNA damage caused by busulfan.
Chidamide is designed to open up the DNA and allow greater access to drugs that bind to DNA, such as cladribine, gemcitabine, busulfan.
详细描述
Study Groups:
If you are found to be eligible to take part in this study, you will be enrolled in a group of at least 3 participants to begin receiving the study drugs.
The dose of the study drugs you receive will depend on when you enrolled in this study. If no intolerable side effects occur in your group, researchers will continue to enroll participants at the next dose level until either the vorinostat reaches the dose level currently used alone without stem cell transplant, or the highest tolerable dose of this drug is found. The dose that you receive will remain the same throughout this study.
You will be admitted to the hospital on Day -6.
Study Drug Administration (for all patients):
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary refractory or recurrent diffuse large B cell lymphoma that do not qualify for treatment protocols of higher priority.
- •Relapsed patients should respond to 2nd or 3rd line salvage chemotherapy and attain at least PR before recruitment.
- •Adequate renal function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinine </= 1.8 mg/dL.
- •Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) </= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase </= 2 x upper limit of normal.
- •Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) >/= 50% of expected corrected for hemoglobin.
- •Adequate cardiac function with left ventricular ejection fraction >/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- •Performance status 0-
- •Negative Beta diffusing capacity of lung for carbon monoxide (HCG) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
排除标准
- •Central nervous system lymphoma
- •Patients relapsed after ASCT
- •Bone marrow was involved by lymphoma
- •Patients with active hepatitis B or C(HBV DNA >/=10,000 copies/mL).
- •Active infection requiring parenteral antibiotics
- •HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal cluster of differentiation 4 (CD4) counts
- •Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
- •Patients with a cQT longer than 500 ms
研究组 & 干预措施
ChiCGB
Experimental: ChiCGB
Chidamide administered orally on D-7, -4, 0,+3
Cladribine administered at 10mg on D-6 to D-2
Gemcitabine administered at 2500 mg/m2 on days -6 and -2.
Busulfan administered at 3.2 mg/kg (adjusted ideal body weight) on days -6 to -3.
Dexamethasone 10 mg by vein daily from day -6 to day -1. Caphosol oral rinses 30 mL four times a day used from day -8.
Interventions:
Drug: Chidamide Drug: Cladribine Drug: Gemcitabine Drug: Busulfan Drug: Dexamethasone Procedure: Stem Cell Transplant
干预措施: Chidamide (Drug)
ChiCGB
Experimental: ChiCGB
Chidamide administered orally on D-7, -4, 0,+3
Cladribine administered at 10mg on D-6 to D-2
Gemcitabine administered at 2500 mg/m2 on days -6 and -2.
Busulfan administered at 3.2 mg/kg (adjusted ideal body weight) on days -6 to -3.
Dexamethasone 10 mg by vein daily from day -6 to day -1. Caphosol oral rinses 30 mL four times a day used from day -8.
Interventions:
Drug: Chidamide Drug: Cladribine Drug: Gemcitabine Drug: Busulfan Drug: Dexamethasone Procedure: Stem Cell Transplant
干预措施: Cladribine (Drug)
ChiCGB
Experimental: ChiCGB
Chidamide administered orally on D-7, -4, 0,+3
Cladribine administered at 10mg on D-6 to D-2
Gemcitabine administered at 2500 mg/m2 on days -6 and -2.
Busulfan administered at 3.2 mg/kg (adjusted ideal body weight) on days -6 to -3.
Dexamethasone 10 mg by vein daily from day -6 to day -1. Caphosol oral rinses 30 mL four times a day used from day -8.
Interventions:
Drug: Chidamide Drug: Cladribine Drug: Gemcitabine Drug: Busulfan Drug: Dexamethasone Procedure: Stem Cell Transplant
干预措施: gemcitabine (Drug)
ChiCGB
Experimental: ChiCGB
Chidamide administered orally on D-7, -4, 0,+3
Cladribine administered at 10mg on D-6 to D-2
Gemcitabine administered at 2500 mg/m2 on days -6 and -2.
Busulfan administered at 3.2 mg/kg (adjusted ideal body weight) on days -6 to -3.
Dexamethasone 10 mg by vein daily from day -6 to day -1. Caphosol oral rinses 30 mL four times a day used from day -8.
Interventions:
Drug: Chidamide Drug: Cladribine Drug: Gemcitabine Drug: Busulfan Drug: Dexamethasone Procedure: Stem Cell Transplant
干预措施: Busulfan (Drug)
ChiCGB
Experimental: ChiCGB
Chidamide administered orally on D-7, -4, 0,+3
Cladribine administered at 10mg on D-6 to D-2
Gemcitabine administered at 2500 mg/m2 on days -6 and -2.
Busulfan administered at 3.2 mg/kg (adjusted ideal body weight) on days -6 to -3.
Dexamethasone 10 mg by vein daily from day -6 to day -1. Caphosol oral rinses 30 mL four times a day used from day -8.
Interventions:
Drug: Chidamide Drug: Cladribine Drug: Gemcitabine Drug: Busulfan Drug: Dexamethasone Procedure: Stem Cell Transplant
干预措施: Autologous hematopoietic stem cell transplantation (Procedure)
结局指标
主要结局
Event free survival
时间窗: 2 years
次要结局
- Adverse events(2 years)
- Overall survival(2 years)
- Complete remission(3 month after autologous hematopoietic stem cell transplantation)
研究者
Jie Ji
Clinical Professor
Sichuan University