A Prospective, Single-Center Study Evaluating the Efficacy and Safety of Glofitamab Combined With Orelabrutinib and Bortezomib in Patients With High-Risk Mantle Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 29
- 主要终点
- Complete Response (CR) Rate
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of Glofitamab combined with Orelabrutinib and Bortezomib in patients with high-risk mantle cell 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form
- •Age ≥ 18 years at the time of signing Informed Consent Form and willingness to comply with study protocol procedures
- •Participants with MCL
- •Meets any of the following high-risk criteria: blastoid/pleomorphic morphology; high Ki-67 (≥ 30%); TP53 aberration; del(17p); complex karyotype; MIPI score ≥ 6.2; early progression after first-line treatment (<24 months); presence of other high-risk genetic mutations (KMT2D, NSD2, NOTCH1, CDKN2A, NOTCH2, SMARCA4, CCND1)
- •Life expectancy ≥ 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
- •At least one bi-dimensionally measurable (≥ 1.5 cm) nodal lesion, or one bi-dimensionally measurable (≥ 1 cm) extranodal lesion, as measured on CT scan
- •No bone marrow involvement: ANC ≥ 1.0 × 10^9/L; bone marrow involvement: ANC ≥ 0.5 × 10^9/L
- •No bone marrow involvement: PLT ≥ 75 × 10^9/L; bone marrow involvement: PLT ≥ 25 × 10^9/L
- •No bone marrow involvement: Hgb ≥ 8 g/dL; bone marrow involvement: Hgb ≥ 7 g/dL
- •Adequate renal function, defined as measured or estimated creatinine clearance ≥ 30 mL/min
排除标准
- •Contraindication to any of the individual components of Glofit-Orela-Borte
- •Known active infection at the time of enrollment
- •Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology): Patients with occult or prior HBV infection (defined as negative HbsAg and positive hepatitis B core antibody [HbcAb]) may be included if HBV DNA is undetectable, provided that they are willing to undergo DNA testing on Day 1 of every cycle and every three months for at least 12 months after the last cycle of study treatment and appropriate antiviral therapy
- •Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing): Patients who are positive for HCV antibody are eligible only if PCR is negative for HCV RNA
- •History of other malignancies that could affect compliance with the protocol or interpretation of results
- •Active autoimmune disease requiring treatment
- •Primary or secondary CNS lymphoma at the time of recruitment
- •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications
研究组 & 干预措施
Glofitamab-Orelabrutinib-Bortezomib
Participants will receive 2000 mg of obinutuzumab on Days 1-2 of Cycle 1, 2.5 mg of glofitamab on Day 8 of Cycle 1, 10 mg of glofitamab on Day 15 of Cycle 1, followed by 30 mg of glofitamab on Day 1 of Cycles 2-12.
Participants will receive 1.6 mg/m² of bortezomib on Days 1, 8, and 15 of Cycles 1-12.
Participants will receive 150 mg/day of orelabrutinib on Days 1-21of Cycles 1-12.
The duration of one cycle is 21 days.
干预措施: Obinutuzumab (Drug)
Glofitamab-Orelabrutinib-Bortezomib
Participants will receive 2000 mg of obinutuzumab on Days 1-2 of Cycle 1, 2.5 mg of glofitamab on Day 8 of Cycle 1, 10 mg of glofitamab on Day 15 of Cycle 1, followed by 30 mg of glofitamab on Day 1 of Cycles 2-12.
Participants will receive 1.6 mg/m² of bortezomib on Days 1, 8, and 15 of Cycles 1-12.
Participants will receive 150 mg/day of orelabrutinib on Days 1-21of Cycles 1-12.
The duration of one cycle is 21 days.
干预措施: Glofitamab (Drug)
Glofitamab-Orelabrutinib-Bortezomib
Participants will receive 2000 mg of obinutuzumab on Days 1-2 of Cycle 1, 2.5 mg of glofitamab on Day 8 of Cycle 1, 10 mg of glofitamab on Day 15 of Cycle 1, followed by 30 mg of glofitamab on Day 1 of Cycles 2-12.
Participants will receive 1.6 mg/m² of bortezomib on Days 1, 8, and 15 of Cycles 1-12.
Participants will receive 150 mg/day of orelabrutinib on Days 1-21of Cycles 1-12.
The duration of one cycle is 21 days.
干预措施: Bortezomib (Drug)
Glofitamab-Orelabrutinib-Bortezomib
Participants will receive 2000 mg of obinutuzumab on Days 1-2 of Cycle 1, 2.5 mg of glofitamab on Day 8 of Cycle 1, 10 mg of glofitamab on Day 15 of Cycle 1, followed by 30 mg of glofitamab on Day 1 of Cycles 2-12.
Participants will receive 1.6 mg/m² of bortezomib on Days 1, 8, and 15 of Cycles 1-12.
Participants will receive 150 mg/day of orelabrutinib on Days 1-21of Cycles 1-12.
The duration of one cycle is 21 days.
干预措施: Orelabrutinib (Drug)
结局指标
主要结局
Complete Response (CR) Rate
时间窗: Up to 2 years
CR rate, defined as the proportion of patients with a best overall response of CR at any time during the study, as determined by the investigator using 2014 Lugano Response Criteria
次要结局
- Objective Response Rate (ORR)(Up to 2 years)
- Duration of Response (DoR)(Up to 2 years)
- Duration of Complete Response (DoCR)(Up to 2 years)
- Progression-Free Survival (PFS)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Incidence and severity of adverse events(Up to 2 years)