A Study of High Dose Gemcitabine, Busulfan and Thiotepa With Autologous Stem Cell Transplantation for Primary or Relapse Central Nervous System Lymphomas
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The goal of this single-arm, prospective study is to learn if high dose gemcitabine, busulfan and thiotepa with autologous stem cell transplantation to treat primary or relapse central nervous system lymphomas. It will learn about the safety and efficacy of combination therapy. The main question it aims to answer is:
Efficacy and safety of the combination of high dose gemcitabine, busulfan and thiotepa as a bridging therapy to ASCT in patients with CNSL.
Participants will:
Take gemcitabine (2.5 g/m²) was administered intravenously (IV) on Days -9 and -3, Busulfan (3.2 mg/kg) was given IV over 3 hours on Days -9 to -7, and thiotepa (5 mg/kg) was administered IV on Days -5, -4, and -3. Peripheral stem cells were infused on Day 0.
Visit the clinic for checkups and tests in accordance with the International Primary CNS Lymphoma Group (IPCG).
Researchers will observe the patients receiving GemBuTT regimen as conditioning therapy in CNSL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 70 years;
- •CNS status of complete remission (CR) or partial response (PR) as assessed by magnetic resonance imaging (MRI), positron emission tomography-computed tomography (PET/CT), or CSF analysis (if applicable);
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2;
- •absence of systemic lymphoma in the neck, chest, abdomen, and pelvis as assessed by CT and bone marrow biopsy;
- •negative HIV and hepatitis virus infections (particularly hepatitis B or C, with HBV DNA ≥ 10,000 copies/mL);
- •left ventricular ejection fraction (LVEF) ≥50% and no uncontrolled arrythmias or symptomatic cardiac disease;
- •forced expiratory volume in one second (FEV1) ≥70%;
- •serum creatinine clearance ≥ 50 ml/min and/or serum creatinine ≤ 1.8 mg/dL;
- •serum bilirubin ≤ 2 times the upper limit of normal, serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) ≤ 3 times the upper limit of normal.
排除标准
- •relapse after stem cell transplantation;
- •other uncontrolled malignancies;
- •immunodeficiency;
- •active infection requiring parenteral antibiotics;
- •pregnant or lactation;
- •severe psychiatric or psychological conditions.
研究组 & 干预措施
Gemcitabine, busulfan and thiotepa as conditioning therapy
Gemcitabine (2.5 g/m²) (Days -9 and -3), Busulfan (3.2 mg/kg) (Days -9 to -7), and Thiotepa (5 mg/kg) (Days -5, -4, and -3) were all administered intravenously.
干预措施: High dose Gemcitabine, Busulfan, and Thiotepa as conditioning therapy (Drug)
结局指标
主要结局
PFS
时间窗: 2 years from ASCT
The time from stem-cell reinfusion to disease progression, relapse, or death from any cause
次要结局
- OS(2 years post ASCT)
- non-relapse mortality (NRM)(100 days)
- Hematopoietic recovery(30 days)
- Non-hematological adverse events (AEs)(2 months)
- Lymphoma relapse or progression(2 years)
研究者
Jie Ji
Clinical Professor
Sichuan University