NCT01272817已完成不适用
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using Antithymocyte Globulin With Either Melphalan and Cladribine or Total Lymphoid Irradiation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Engraftment
研究概览
简要总结
Allogeneic transplant from a matched sibling for the treatment of a variety of illnesses including bone marrow failure states, leukemias, myelodysplastic or myeloproliferative syndromes, lymphoma, or myeloma using a nonmyeloablative preparative regimen.
详细描述
same
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 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 55 years or
- •Age < 55 and LVEF < 45% or creatinine clearance < 60 ml/min
- •Ability to cover the cost of the transplant, necessary medications, and transportation/housing.
- •Caregiver must be available while outpatient
- •Guidelines for Cladribine-Melphalan-based conditioning:
- •Bone Marrow Failure States Severe Aplastic Anemia (relapsed following immunosuppressive therapy) Paroxysmal Nocturnal Hemoglobinuria (poor prognostic features or hemosiderosis)
- •AML (first CR except for t(15;17), inv16, t(8,21); second CR; relapse failing second induction attempt)
- •ALL (first CR with at least one poor prognostic feature; second or greater CR; relapse failing reinduction attempt)
- •MDS (RAEB, RAEBiT, CMMoL)
- •CML (chronic phase; accelerated phase; blast phase following reinduction attempt; 2nd chronic or accelerated phase following gleevec therapy
- •Hodgkin's lymphoma (first or greater relapse)
- •Non-Hodgkin's Lymphoma
- •Aggressive Histology (includes T Cell NHL) Incomplete response to induction Second CR Sensitive or refractory relapse
- •Indolent Histology Second or greater relapse
- •Mantle Cell Lymphoma (any Stage - must have received induction chemotherapy)
- •Multiple Myeloma (10% residual plasmacytosis following anthracycline-based chemotherapy or residual disease following autologous transplant)
- •Waldenstrom Macroglobulinemia (must have failed either purine analogue-based chemotherapy (Fludara or 2CdA) or standard CVP therapy; hyperviscosity or cytopenias)
- •Guidelines for total lymphoid irradiation-based conditioning
- •MDS (RA, RARS)
- •CLL (Rai stage III or IV - must have received at least two different treatment regimens in the past)
- •Breast Cancer (symptomatic metastatic disease, who have failed standard chemotherapy)
- •Renal Cell Cancer (metastatic disease at multiple sites)
- •Malignant Melanoma (metastatic disease at multiple sites)
- •Sarcoma (all subtypes presently, unresectable metastatic disease)
- •Ovarian Cancer (stage III or IV, platinum insensitive disease, i.e. progression within 6 months of initial platinum chemotherapy)
- •Thymoma (unresectable disease)
排除标准
- •Prior allogeneic stem cell or bone marrow transplant
- •Current or past history of invasive mycotic infection
- •Breast Feeding
研究组 & 干预措施
Cladribine + melphalan
Other
Cladribine + melphalan conditioning
干预措施: Nonmyeloablative Allogeneic Transplant (Procedure)
TLI
Other
Total lymphoid irradiation conditioning
干预措施: Nonmyeloablative Allogeneic Transplant (Procedure)
结局指标
主要结局
Engraftment
时间窗: One year
Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant.
次要结局
- Graft-versus-host disease(One year)
研究者
研究点 (1)
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