Risk Adapted Therapy Optimization for Patients With Relapsed or Refractory Aggressive Non-Hodgkin-Lymphoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Toxicity
研究概览
简要总结
This study investigates toxicity and efficacy of 2 x R-DHAP followed by High dose chemotherapy R-TEC and autologous stem cell transplantation in patients with relapsed or refractory aggressive Non- Hodgkins's Lymphoma.
详细描述
Initial Cytoreduction is performed with DHAP- protocol using dexamethasone, cytarabine and cisplatin followed by high dose chemotherapy with treosulfan, etoposide and cisplatin (TEC) an autologous peripheral blood stem cell transplantation(aPBSCT). In case of only partial remission a second identical high dose chemotherapy and aPBSCT follows. Patients with primary refractory disease or early relapse within 6 months should receive a allogenous stem cell transplantation. For Patients with CD 20 positive B-cell lymphoma the chemotherapy regiments DHAP and TEC are combined with rituximab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first relapse or primary refractory disease of aggressive Non-Hodgkin's lymphoma stage I-IV
- •pretreatment with systemic therapy
- •18-65 years of age
- •Performance status:ECOG 0-2
- •Granulocyte count >1.5/µm3, Platelet count >100/µm3
- •Creatinine -Clearance ≥ 1 ml/sec
- •GPT/GOT ≤ 1.5 x normal (except tumour related)
- •Bilirubine < 22 µmol/l
- •no participation in another study 3 month before and during this study
- •informed consent
排除标准
- •Second neoplasia in history or existing except basalioma or squamous epithelium carcinoma of the skin or removed cervical intraepithelial neoplasia
- •CNS- involvement by lymphoma
- •respiratory Partial- or global insufficiency
- •cardiac insufficiency (NYHA-Stage 3-4, EF < 30 %)
- •severe neurological or psychiatric disease
- •pregnancy
- •HIV positivity ,active virus hepatitis, bacterial infection
- •No follow up procedures ensured
结局指标
主要结局
Toxicity
次要结局
- overall survival
- relapse free survival
- remission rate
- remission duration