A Single Arm, Phase II Clinical Trial of Orelabrutinib Combined With Pemetrexed in the Treatment for Patients With Relapsed/Refractory Central Nervous System Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- objective response rate
研究概览
简要总结
This is a prospective single arm, phase II clinical trial to observe the efficacy and safety of orelabrutinib combined with pemetrexed in the treatment for patients with relapsed/refractory central nervous system 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
- •Age between 18 to 75 years old (including 18 and 75)
- •Diagnosed as diffuse large B-cell lymphoma; Recurrence or progression of central nervous system disease confirmed by imaging ± tissue biopsy pathology or cerebrospinal fluid flow cytometry; Secondary central nervous system lymphoma can also be admitted when the systemic disease is well controlled
- •Having at least one measurable lesions
- •World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 ( ECOG 3 due to tumors can be included after being fully assessed by the investigator)
- •Life expectancy no less than 1 month
- •enough main organ function
- •Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
- •Agreeing to sign the written informed consents
排除标准
- •Poor peripheral disease control of secondary central nervous system lymphoma
- •Patients used pemetrexed or orelabrutinib in the past
- •Active malignant tumor need be treated at the same time
- •Other malignant tumor history
- •Serious surgery and trauma less than two weeks
- •Patients with active tuberculosis
- •Systemic therapy for serious acute/chronic infection
- •Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
- •HIV-positive, AIDS patients and untreated active hepatitis
- •Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
- •Patients with a history of mental illness or drug abuse
- •Poor compliance during the trial and/or follow-up phase
- •Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial
- •Researchers determine unsuited to participate in this trial
研究组 & 干预措施
Orelabrutinib Combined with Pemetrexed
Induction Chemotherapy: Orelabrutinib, 150mg/d continuous oral administration, Pemetrexed, 500mg/m2, Intravenous administration on day 5 of each 3-week cycle (Total 6 cycles).
Maintenance Treatment: Orelabrutinib, 150mg/d continuous oral administration (28d/cycle).
干预措施: ICP-022 (Drug)
Orelabrutinib Combined with Pemetrexed
Induction Chemotherapy: Orelabrutinib, 150mg/d continuous oral administration, Pemetrexed, 500mg/m2, Intravenous administration on day 5 of each 3-week cycle (Total 6 cycles).
Maintenance Treatment: Orelabrutinib, 150mg/d continuous oral administration (28d/cycle).
干预措施: Pemetrexed (Drug)
结局指标
主要结局
objective response rate
时间窗: every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment to 5 years after last patient's enrollment (each cycle is 28 days)
the total proportion of patients with complete response (CR) and partial response (PR)
次要结局
- progression-free survival(every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment to 5 years after last patient's enrollment (each cycle is 28 days))
- The incidence of grade 3-4 adverse events(up to 5 years)
- overall survival(every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment to 5 years after last patient's enrollment (each cycle is 28 days))
研究者
Zhihua Yao, PhD
Director
Henan Cancer Hospital