The Efficacy and Safety of Azacitidine in Combination With Chidamide in the Treatment of Newly Diagnosed Peripheral T-Cell Lymphoma Unfit for Conventional Chemotherapy
试验速览
- 阶段
- 2 期
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
This prospective, open-label, single-arm study will evaluate the efficacy and safety of azacitidine in combination with chidamide in treatment of newly diagnosed peripheral T-cell lymphoma unfit for conventional chemotherapy.
详细描述
Peripheral T-cell lymphoma (PTCL is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for ~10%. CHOP regimen has been widely used in PTCL patients even with unfavourable prognosis, with 5-year overall survival rate of 38.5%. Elderly patients seldom benefit from conventional CHOP regimen. A study showed that CR rate was only 18.1% in elderly patients (median age of 80 years old, ranging from 56 to 93 years old).
Azacitidine combined with romidepsin has been proved efficient in relasped or refractory PTCL, with CR rate of 55%. This prospective, open-label, single-arm study will evaluate the efficacy and safety of azacitidine in combination with Chidamide in treatment of newly diagnosed peripheral T-cell lymphoma unfit for conventional chemotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed peripheral T-cell lymphoma based on 2016 WHO classification
- •Treatment naive
- •Age ≥ 18 years
- •Unfit for converntional chemotherapy meeting criteria as following but not limited to: age ≥75, ECOG >2，ADL<100 or CCI>
- •Must has measurable lesion in CT or PET-CT prior to treatment
- •Expected lifetime ≥ 3 months
- •Informed consented
排除标准
- •Has accepted localized or systemic anti-lymphoma treatment
- •Has accepted autologous Stem cell transplantation before
- •History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix prior to study treatment
- •Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- •Primary CNS lymphoma
- •Left EF≤ 50%
- •Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/ L ;Platelet<75*10^9/L; ALT or AST >2*ULN; Creatinine>1.5*ULN
- •Other uncontrollable medical condition that may that may interfere the participation of the study
- •Not able to comply to the protocol for mental or other unknown reasons
- •Patients with mentally disorders or other reasons unable to fully comply with the study protocol
- •Pregnant or lactation
- •HIV infection
- •HBV-DNA and HCV-RNA undectable.
研究组 & 干预措施
Aza+Chida
Azacitidine ivgtt D1-7 Chindamide 30mg,PO,twice a week Every 21 days for total 6 courses
干预措施: Azacitidine (Drug)
Aza+Chida
Azacitidine ivgtt D1-7 Chindamide 30mg,PO,twice a week Every 21 days for total 6 courses
干预措施: Chidamide (Drug)
结局指标
主要结局
Complete response rate
时间窗: At the end of Cycle 6 (each cycle is 21 days)
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
次要结局
- Overall response rate(At the end of Cycle 6 (each cycle is 21 days))
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE(Baseline up to data cut-off (up to approximately 4 years))
- Overall survival(Baseline up to data cut-off (up to approximately 4 years))
- Treatment related mortality(Baseline up to data cut-off (up to approximately 4 years))
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores(: Baseline (pre-dose [Hour 0] on Cycle1 Day1), Cycle3 Day 1, end of treatment (up to Month 6), every 3 months 1st year, every 6 months 2nd year, and 12 months thereafter up to data cut-off, up to approximately 4 years (cycle length = 21 days))
- Duration of response(Baseline up to data cut-off (up to approximately 4 years))
- Progression free survival(Baseline up to data cut-off (up to approximately 4 years))
研究者
Zhao Weili
First Deputy Director，Hematology Department
Ruijin Hospital