A Prospective, Multicenter, Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of Rituximab, Pirtobrutinib, High-Dose Methotrexate, Dexamethasone, and Thiotepa (R-PMDT) in Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 1
研究概览
简要总结
A total of six cycles of the R-PMDT regimen (rituximab, pirtobrutinib, high-dose methotrexate, dexamethasone, and thiotepa) will be administered to patients with newly diagnosed primary central nervous system lymphoma (PCNSL). The primary objective is to assess the overall response rate (ORR) of R-PMDT. Secondary objectives include evaluating the complete response rate, progression-free survival (PFS), overall survival (OS), and safety.
详细描述
In this prospective, multicenter, open-label, single-arm phase 2 clinical trial, eligible patients with newly diagnosed primary central nervous system lymphoma (PCNSL) will receive six cycles of the R-PMDT regimen. The R-PMDT regimen is administered as follows: rituximab (R, 375 mg/m²) is given as an intravenous infusion on day 0; methotrexate (M, 3.5 g/m²) is administered as a 3-hour intravenous infusion on day 1, with dose adjustment based on pre-treatment creatinine clearance; dexamethasone (D, 20 mg) is given intravenously on days 1-4; thiotepa (T, 30 mg/m²) is administered intravenously on day 1; and pirtobrutinib (P, 200 mg once daily) is taken orally on days 4-21. After completion of six cycles, depending on the investigator's decision, patients may receive consolidation or maintenance therapy, including but not limited to autologous hematopoietic stem cell transplantation, radiotherapy, or pirtobrutinib maintenance. The primary objective is to assess the overall response rate (ORR) of R-PMDT. Secondary objectives include evaluation of the complete response rate, progression-free survival (PFS), overall survival (OS), and safety.
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
- •Newly diagnosed primary central nervous system diffuse large B-cell lymphoma
- •Adequate hematologic function: ANC ≥1.0×10⁹/L, PLT ≥75×10⁹/L
- •Adequate hepatic function: ALT/AST ≤3×ULN; total bilirubin ≤1.5×ULN
- •Adequate renal function: serum creatinine ≤2×ULN or CrCl ≥40 mL/min
- •LVEF ≥55% by echocardiography
- •Baseline oxygen saturation >92% on room air
- •Expected survival ≥3 months
排除标准
- •Prior anti-lymphoma therapy other than corticosteroids.
- •Uncontrolled significant cardiovascular or cerebrovascular disease.
- •Uncontrolled active systemic bacterial, fungal, or viral infection.
- •Active hepatitis B and/or active hepatitis C (HCV RNA positive). Patients with positive hepatitis B surface antigen and/or core antibody but HBV-DNA < 1000 IU/mL may be included and should receive concurrent oral antiviral prophylaxis against HBV reactivation.
- •Hypersensitivity to any study drug or its components.
- •Other active malignancy, except for adequately controlled non-melanoma skin cancer, in situ carcinoma, or malignancy that has been in complete remission for ≥5 years.
- •Pregnant or lactating women. Fertile patients unwilling to use effective contraception.
- •Other conditions deemed inappropriate by the investigator.
研究者
Zou Dehui
Director of Lymphoma Center Transplantation and Cellular Therapy Unit
Institute of Hematology & Blood Diseases Hospital, China