EUCTR2009-018083-94-IT进行中（未招募）不适用
onmyeloablative Hematopoietic Stem Cell Transplantation for Patients with High-Risk Hematologic Malignancies using Related, HLA-Haploidentical Donors: A Phase II Trial of Combined Immunosuppression with cyclophosfamide administered Before and After Transplantation. A monocentric study. - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •oPatients =70 years old
- •oEligible diagnoses:
- •-CML in AP
- •-AML with high-risk cytogenetics [del(5q)/-5, del(7q)/-7, abnormal 3q, 9q, 11q, 20q, 21q, 17p, t(6:9), t(9;22), complex karyotypes (=3 abnormalities)] in CR1
- •-AML = CR2; patients should have <5% marrow blasts at the time of transplant
- •-High-risk ALL
- •-MDS (>int-1 per IPSS) after = 1 prior cycle of induction chemotherapy; should have<5% marrow blasts at the time of transplant
- •-MM Stage II or III patients who have progressed after an initial response to chemotherapy or autologous HSCT or MM patients with refractory disease who may benefit from tandem autologous-nonmyeloablative allogeneic transplant
- •-CLL, NHL or HD who are ineligible for autologous HSCT or who have resistant/refractory disease and who may benefit from tandem autologous nonmyeloablative allogeneic transplant.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Cross-match positive with donor
- •-Patients with suitably matched related or unrelated donors
- •-Patients with conventional transplant options (a conventional transplant should be the priority for eligible patients = 50 yr of age who have a related donor mismatched for a single HLA-A, -B or DRB1 antigen)
- •-Presence of active, serious infection (e.g., mucormycosis, uncontrolled aspergillosis,
- •-tuberculosis)
- •-Patients with the following organ dysfunction:
- •oLeft ventricular ejection fraction <35%
- •oDLCO <35% and/or receiving supplemental continuous oxygen
- •oLiver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of
- •-HIV-positive patients
- •-Women of childbearing potential who are pregnant (ß-HCG+) or breast feeding
- •-Fertile men and women unwilling to use contraceptives during and for 12 mo posttransplant
- •-Life expectancy severely limited by diseases other than malignancy
研究者
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