IRCT138706061030N2已完成2 期
Haploidentical Hematopoietic Stem Cell Transplantation in the Treatment of Hematological Malignancies Using CAMPATH-1H
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65 years(—)
- 性别
- All
入选标准
- •Inclusion Criteria:
- •Ages 5-50 years
- •Acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL)
- •Second remission (CR2) in standard risk patients or CR1 in cases with high-risk features (poor cytogenetic changes or secondary to myelodysplastic syndrome)
- •Unavailability of HLA identical related donor or matched unrelated donor.
- •Unavailability of other therapeutic intervention that prolongs patient survival.
- •No history of allergy to CAMPATH.
- •The donor must be haploidentical with the recipient.
- •Weight greater than or equal to 18 kg.
- •Age between 2 and 60 years old.
- •Negative two-way WBC crossmatch with the recipient.
排除标准
- •Major anticipated illness or organ failure incompatible with survival from transplantation.
- •Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the transplantation procedure unlikely and making informed consent impossible.
- •HIV positive
- •Active infection
- •Positive pregnancy test for women of childbearing age.
- •Left ventricular ejection fraction less than 40%
- •AST/SGOT greater than 20 x ULN (CTCAE grade IV v3.0)
- •Bilirubin greater than 10 x ULN (CTCAE grade IV v3.0)
- •Creatinine greater than 6 x ULN (CTCAE grade IV v 3.0)
- •Pregnant or lactating
- •Unfit to receive filgrastim (G-CSF) and undergo apheresis (abnormal blood counts, history of stroke, uncontrolled hypertension)
- •Sickling hemoglobinopathies including HbSS, HbAS, HbSC
- •HBsAg positive
- •CMV positive (for CMV negative recipients)
研究者
相似试验
已完成
1 期
Haploidentical hematopoietic stem cell transplantation in combination with posttransplant cyclophosphamide and ATG-thymoglobulin Phase I studyhematological malignancyJPRN-UMIN000009374ational Cancer Center Hospital15
已完成
1 期
Haploidentical hematopoietic stem cell transplantation with posttransplant cyclophosphamide in combination with thymoglobulin (RIC version) Phase IHematological malignancyJPRN-UMIN000011004ational Cancer Center Hospital12
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. - NDHigh risk Hematologic MalignanciesMedDRA version: 9.1Level: HLGTClassification code 10024324MedDRA version: 9.1Level: HLGTClassification code 10025323EUCTR2009-018083-94-ITISTITUTO EUROPEO DI ONCOLOGIA
招募中
1 期
Blood Stem Cell transplantation with low dose chemo/radiotherapy for patients with High-Risk solid tumors using related identical donors or 50% compatible donorsEUCTR2012-002464-27-ITISTITUTO EUROPEO DI ONCOLOGIA20
进行中(未招募)
1 期
Stem cells transplant from matched donor in patients with chronic myeloid leukemia who do not improve with TKI therapyChronic Myeloid LeukemiaMedDRA version: 18.0Level: LLTClassification code 10054352Term: Chronic phase chronic myeloid leukemiaSystem Organ Class: 100000004864EUCTR2014-003126-40-ITIVERSITà DEGLI STUDI MILANO BICOCCA20
