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临床试验/NCT01683123
NCT01683123已完成不适用

Phase 2 Study With Intravenous Busulfan And Fludarabine Myeloablative Conditioning For HLA Identical Sibling Allogeneic HSCT In Myeloid Malignancies. Retrospective Analysis.

Grupo Espanol de trasplantes hematopoyeticos y terapia celular0 个研究点目标入组 143 人开始时间: 2007年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
143

研究概览

简要总结

Analyze the results of conditioning with once-daily dose intravenous busulfan and fludarabine in patients undergoing HLA identical sibling Allogeneic HSCT for myeloid malignancies.

详细描述

In this study the investigators evaluate a conditioning regimen consisting in Fludarabine 40 mg/m2 once daily i.v in 60 min. on days -6 to -3 (total dose 160 mg/m2), followed by Busulfan 3,2 mg/kg once daily i.v. in 180 min. in the same days (total dose 12,8 mg/kg). No busulfan pharmacokinetic monitoring is performed. Graft versus host disease prophylaxis consists in the combination of cyclosporine and methotrexate. Graft products obtained from bone marrow or peripheral blood of HLA identical sibling donors are not manipulated in their cellular content before transplantation. Blood products were leukocyte depleted and irradiated before transfusion. Supportive care, including seizure prophylaxis, isolation measures, antiemetics, antimicrobial agents and growth factors use are followed according to standard procedures.

The main objectives are to record data regarding engraftment, regimen related toxicity and outcome in different patient populations according to age, disease type, disease status at HSCT and comorbidities.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Myeloproliferative Disorders
  • Chronic Myeloid Leukemia

排除标准

  • Performance status ECOG>2
  • Cardiomyopathy (LVEF <39%)
  • Pulmonary dysfunction (DLCO<39%)
  • Hepatic dysfunction Grade >1
  • Renal dysfunction Grade >1 (Creatinine > 1.6 mg/dl)
  • HIV infection
  • Other active neoplasm

研究者

发起方
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
申办方类型
Other
责任方
Sponsor

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