A Prospective Phase II Study to Evaluate Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
Indication: Patients with advanced lymphoid malignancies in the absence of an HLA identical or mismatch donor.
Objectives: Overall survival at one year. Efficacy >60%, rejection rate <20%. Inclusion criteria: Age: 18-65 years old, no sibling or unrelated donor identified, low grade non-hodgkin lymphoma in third line (who already received at least one autologous transplantation); hodgkin lymphoma in early relapse (<1 year), who received at least one autologous transplantation and sensible to chemotherapy and CLL with 17p deletion or in relapse less than 2 year after a fludarabine nbased regimen or in relapse after one autologous transplantation.
Stem cell source: Two cord blood units containing both together more than 3x107 frozen nucleated cells/Kg with no more than 2 out of 6 HLA mismatches between them and with the patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 years old
- •no sibling or unrelated donor identified (9/10 or 10/10)
- •with either one of these advanced lymphoid malignancies
- •low grade non-hodgkin lymphoma in third line (who already received at least one autologous transplantation)
- •hodgkin lymphoma in early relapse (<1 year)who received at least one autologous transplantation and sensible to chemotherapy
- •CLL with 17p deletion or in relapse less than 2 year after a fludarabine nbased regimen or in relapse after one autologous transplantation.
排除标准
- •No patient signed consent
- •Previous allograft
- •Psychiatric conditions
- •HIV positive
- •HVC hepatitis requiring treatment
- •Previous total body irradiation (TBI)
- •Any contraindication to TBI
- •Any contraindication to allograft, such as cardiovascular, respiratory, renla or liver dysfunctions
- •No Health care insurance
研究组 & 干预措施
Cord blood transplantation
Two cord blood units containing both together more than 3x10^7 frozen nucleated cells/Kg with no more than 2 out of 6 HLA mismatches between them and with the patients.
干预措施: Cord Blood Transplantation (Other)
结局指标
主要结局
Overall survival
时间窗: 1 year
次要结局
- Relapse free survival(2 years)
- Acute Graft versus host disease (GvHD)(100 days)
- toxicity(2 years)
- Relapse rate(within the 2 years after inclusion)
- Immunologic reconstitution(D30, D60, D100, M6, M12 and M24)
- Incidence of severe infectious complications(D100 and M12)
- Engraftment(100 days)
- Chimerism(D15, D30, D60, D100, M6, M12 and M24)
- Chronic graft versus host disease (GVHD)(within 2 years after inclusion)