Orelabrutinib Combined With Obinutuzumab and Lenalidomide (OGL Regimen) as First-line Treatment for Marginal Zone Lymphoma：a Multicenter Prospective Single Arm Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- the best complete response rate
研究概览
简要总结
This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with obinutuzumab and lenalidomide in untreated marginal zone lymphoma. The primary objective was the best complete response rate (CRR).
详细描述
Marginal zone lymphomas (MZL) are a type of lymphoma that originates from the marginal zone tissue of the lymphoid follicles (Mucosa-associated lymphoid tissue, MALT), and include three subtypes: MALT lymphoma, nodal MZL, and splenic MZL. The incidence of MZL is second only to diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL), accounting for approximately 7.8% of all non-Hodgkin lymphomas (NHL). MZL is considered an indolent lymphoma, with patients generally having a better overall survival prognosis. Despite this, some patients still face the challenges of disease relapse or transformation into large cell lymphoma, leading to a poor prognosis.
We conduct this prospective, phase II, single-arm clinical study to initially explore the efficacy and safety of Orelabrutinib combined with obinutuzumab and lenalidomide in patients with previously untreated marginal zone lymphoma. The patients will be treated with 6 cycles of OGL regimen. Patients with CR/PR after 6 cycles of OGL treatment will be treated with 6 cycles of single-agent orelabrutinib regimen.
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
- •Age ≥ 18 years, either sex.
- •Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).
- •At least 1 measurable lesion
- •Eligible for treatment: meets the GELF criteria, or has clinical symptoms/organ dysfunction related to the disease
- •Patients who are not suitable for local radiotherapy or whose condition progresses after local treatment, and those not suitable for local radiotherapy include the following situations:
- •Ann Arbor non-continuous Stage II or Stage III-IV non-gastric MALT and nodal MZL
- •SMZL (Splenic Marginal Zone Lymphoma)
- •Gastric MALT with Lugano Stage II2/IIE/IV
- •ECOG performance status (PS) score of 0-
- •Expected survival time is ≥3 months
- •Sign the Informed consent
排除标准
- •Currently has other malignant tumors;
- •Lymphoma involving the central nervous system
- •Allergic to any of the study drugs;
- •Active infection or uncontrolled HBV infection (DNA>105/ml), HIV/AIDS, or other severe infectious diseases;
- •Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;
- •Any other conditions deemed unsuitable for participation in this trial by the investigator.
研究组 & 干预措施
OGL
Orelabrutinib: 150mg qd d1-d21/C1-C6 obinutuzumab: 1000mg iv d1,d8,d15/c1, 1000mg iv d1/C2-C6 lenalidomide：25mg po qd d1-14/C1-C6 Orelabrutinib: 150mg qd d1-d28/C7-C12
干预措施: Orelabrutinib, obinutuzumab, lenalidomide (Drug)
结局指标
主要结局
the best complete response rate
时间窗: At the end of cycle 12(the first 6 cycles are 21 days each, and the following 6 cycles are 28 days each)
CRR is defined as the proportion of patients with a best response of CR
次要结局
- ORR(At the end of therapy(up to 42 weeks))
- CRR(At the end of therapy(up to 42 weeks))
- The best ORR(At the end of cycle 12(the first 6 cycles are 21 days each, and the following 6 cycles are 28 days each))
- TTR(Up to 2 years)
- 2 years progression-free survival Progression free survival (PFS)(From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years])
- Duration of Response (DOR)(Up to 2 years)
- 2 years overall survival(From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years])
- The occurrence of adverse events and serious adverse events(One month after the end of treatment（up to 46 weeks）)