Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients: a Single-arm, Multicenter, Phase II Clinical Trial（Rocket Trial）
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 39
- 试验地点
- 11
- 主要终点
- 2-year event-free survival (EFS) rate
研究概览
简要总结
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of orelabrutinib combined with the R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) regimen as first-line treatment in CD5-positive diffuse large B-cell lymphoma (DLBCL) patients.
详细描述
The purpose of this phase II clinical trial is to evaluate the efficacy and safety of orelabrutinib in combination with R-CHOP for untreated CD5-positive DLBCL patients.
The induction phase consisted of 6 cycles of orelabrutinib in combination with R-CHOP (orelabrutinib added from the second cycle), followed by 2 cycles of rituximab + orelabrutinib, for a total of 8 treatment cycles. After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with orelabrutinib will be conducted.
The primary endpoint is the 2-year event-free survival (EFS) rate.
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
- •Subjects fully understand and voluntarily participate in this study and sign informed consent.
- •Aged ≥18 years, both male and female.
- •Pathologically confirmed CD5-positive DLBCL
- •There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
- •Eastern Cooperative Oncology Group(ECOG) performance status score of 0-
- •Expected survival ≥3 months.
- •Sufficient bone marrow, liver, and kidney function.
排除标准
- •DLBCL combined with other types of lymphoma. Transformed DLBCL.
- •DLBCL with central nervous system invasion.
- •The patients had previously received BTK inhibitors.
- •The patients have contraindications to any drug in the combined treatment.
- •Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
- •Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
- •Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.
- •Mentally ill persons or persons unable to obtain informed consent.
- •The investigators think that the patient is not suitable for the study.
研究组 & 干预措施
Orelabrutinib in combination with R-CHOP
Patients with CD5 positive diffuse large B-cell lymphoma will receive orelabrutinib in combination with R-CHOP regimen from the second cycle of R-CHOP (3 weeks per cycle).
After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with orelabrutinib will be conducted.
干预措施: Orelabrutinib Oral Tablet (Drug)
Orelabrutinib in combination with R-CHOP
Patients with CD5 positive diffuse large B-cell lymphoma will receive orelabrutinib in combination with R-CHOP regimen from the second cycle of R-CHOP (3 weeks per cycle).
After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with orelabrutinib will be conducted.
干预措施: R-CHOP Protocol (Drug)
结局指标
主要结局
2-year event-free survival (EFS) rate
时间窗: Defined as the proportion of patients without disease progression, treatment discontinuation, or death for any reason within 24 months of enrollment
To investigate the preliminary anti-tumor efficacy
次要结局
- Complete response rate (CRR)(Up to 8 cycles (each cycle is 21 days))
- Disease-free survival (DFS)(From date of the first complete response until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Objective response rate (ORR)(Up to 8 cycles (each cycle is 21 days))
- Progression-free survival (PFS)(From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Overall survival (OS)(From the date of enrollment until the date of death from ant cause, assessed up to 24 months)
- Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0(Through study completion, an average of 2 years)
研究者
Qingqing Cai
chief physician
Sun Yat-sen University