A Prospective Study of Pirtobrutinib, Lisaftoclax, and Rituximab in the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Objective response rate(ORR)
研究概览
简要总结
This study aims to evaluate the efficacy of combining pirtobrutinib, lisaftoclax, and rituximab (PVR) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of systemic therapy and to explore a more effective treatment strategy for this patient population.
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
- •≥18 years old.
- •Capable of understanding and voluntarily signing written informed consent.
- •ECOG performance 0 ~
- •Anticipated survival ≥3 months
- •Histologically or cytologically confirmed DLBCL.
- •PET-CT-defined measurable disease with a short axis diameter of ≥1.5 cm.
- •Have received at least one prior line of systemic therapy for DLBCL.
- •Resolution of any prior treatment-related non-hematologic toxicities to Grade ≤1 or baseline.
- •Adequate Bone Marrow and Organ Function, defined as:
- •Bone Marrow Function: ANC≥1.5 × 10⁹/L, Platelets ≥80 × 10⁹/L, Hemoglobin ≥80 g/L Hepatic Function: Total bilirubin ≤1.5 × ULN (≤3.0 × ULN if liver metastases present); AST/SGOT and ALT/SGPT ≤2.5 × ULN (≤5.0 × ULN if liver metastases present) Coagulation: INR and aPTT≤1.5 × ULN Renal Function: Serum creatinine ≤1.5 × ULN or estimated creatinine clearance (CrCl) ≥60 mL/min;
- •Subjects with childbearing or childbearing potential must be willing to practice birth control from the date of registration in this study to the follow-up period of the study.
- •Able to swallow tablets/capsules without difficulty.
- •Adhere to scheduled visits, treatment plans, laboratory tests, and other study procedures.
排除标准
- •Prior treatment failure or resistance to pirtobrutinib or BCL2 inhibitors.
- •Prior Anticancer Therapy:Chemotherapy, radiotherapy, immunotherapy, or antibody-based anticancer therapy within the specified washout period.Traditional Chinese herbal medicine with antitumor indications.Small-molecule targeted therapy within 2 weeks before study treatment initiation. ADCs or cytotoxic therapy within 10 weeks before study treatment initiation.
- •Participation in another investigational drug study within 4 weeks prior to the first dose of study treatment.
- •Systemic corticosteroid therapy (>5 days within 14 days prior to treatment) at doses exceeding >10 mg/day dexamethasone (or equivalent) for CNS disease control.
- •Requiring ongoing anticancer therapy.
- •Uncontrolled or Severe Cardiovascular Disease,
- •Active infection requiring IV antibiotics or systemic antimicrobial therapy.
- •Active HBV/HCV:Exceptions. Inactive HBsAg carriers, HBV patients with sustained viral suppression (HBV-DNA < LLOD),HCV-cured patients are allowed.
- •Clinically significant abnormalities affecting drug absorption or prior total gastrectomy/gastric banding.
- •History of hemorrhagic diathesis or requirement for long-term oral anticoagulation.
- •Prior allogeneic hematopoietic stem cell transplantation (HSCT) or planned allogeneic HSCT.
- •Women who are pregnant or breastfeeding.
- •Known allergy to the study drug or its excipients.
- •Active psychiatric illness or history of alcohol/drug abuse .
- •Any uncontrolled illness, organ dysfunction, or medical condition that, in the investigator's judgment, jeopardizes patient safety or adherence to study procedures.
- •Other conditions deemed inappropriate for study participation by the investigator.
研究组 & 干预措施
Pirtobrutinib, Lisaftoclax, and Rituximab
R/R DLBCL patients will receive PVR for a total of 2 treatment cycles (28 days per cycle) in the induction treatment. Patients with CR/PR after two cycles recieve consolidation therapy : ASCT or CAR-T or PVR (R for 6 cycles, PV continued until disease progression or intolerable adverse reactions) or radiotherapy.The patient will be followed up for two years.
干预措施: Pirtobrutinib (Drug)
Pirtobrutinib, Lisaftoclax, and Rituximab
R/R DLBCL patients will receive PVR for a total of 2 treatment cycles (28 days per cycle) in the induction treatment. Patients with CR/PR after two cycles recieve consolidation therapy : ASCT or CAR-T or PVR (R for 6 cycles, PV continued until disease progression or intolerable adverse reactions) or radiotherapy.The patient will be followed up for two years.
干预措施: Lisaftoclax (Drug)
Pirtobrutinib, Lisaftoclax, and Rituximab
R/R DLBCL patients will receive PVR for a total of 2 treatment cycles (28 days per cycle) in the induction treatment. Patients with CR/PR after two cycles recieve consolidation therapy : ASCT or CAR-T or PVR (R for 6 cycles, PV continued until disease progression or intolerable adverse reactions) or radiotherapy.The patient will be followed up for two years.
干预措施: Rituximab (Drug)
结局指标
主要结局
Objective response rate(ORR)
时间窗: At the end of 2 cycles of PVR regimen (each cycle is 28 days)
The rate of patients who achieved CR or PR after 2 cycles of PVR regimen
次要结局
- Complete response rate(CRR)(At the end of 2 cycles of PVR regimen (each cycle is 28 days))
- Adverse Events(During induction treatment)