NL-OMON43292尚未招募2 期
mbilical cord blood transplantation in high-risk hematological patients using stemregenin-1 expanded hematopoietic stem cells.<br>A feasibility study focussing on engraftment and hematopoietic recovery. - Cord Blood Expansion (SR-1)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 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 至 64（—）
入选标准
- •- Age 18-70 years inclusive
- •- Diagnosis of poor-risk hematological malignancy or (V)SAA relapsing after or failing immunosuppressive therapy and meeting the criteria for a MUD allo SCT
- •- Lacking a sufficiently matched volunteer unrelated donor or lacking such a donor within the required time period of <= 2 months in case of urgently needed alloSCT
- •- Availability of 1 (>=5/6) matched UCB graft with a nuclear cell count 2.7 x 107/kg (see paragraph 8.2).
- •- Availability of an back-up autograft, harvested and frozen earlier in the course of treatment, (harvest according to local aphersis policies)
- •- WHO performance status 0-2
- •- Written informed consent
排除标准
- •Bilirubin and/or transaminases > 2.5 x normal value
- •Creatinine clearance < 40 ml/min
- •Cardiac dysfunction as defined by:
- •-Reduced left ventricular function with an ejection fraction < 45% as measured by MUGA scan or echocardiogram (another method for measuring cardiac function is acceptable)
- •- Unstable angina
- •- Unstable cardiac arrhythmias
- •Pulmonary function test with VC, FEV1 and/ or DCO < 50%
- •Active, uncontrolled infection
- •History of high dose (>= 8 Gy) total body irradiation
- •Pregnant or lactating females
- •HIV positivity
研究者
相似试验
Unknown
不适用
mbilical cord blood transplantation in high-risk hematological patients using stemregenin-1 expanded hematopoietic stem cells.A feasibility study focusing on engraftment and hematopoietic recovery.single cord blood transplantationstemregenin-1 expanded hematopoietic stem cellsengraftmentNL-OMON26058Erasmus MC10
进行中（未招募）
1 期
mbilical cord blood transplantation in high-risk hematological patients using stemregenin-1 expanded hematopoietic stem cells.A feasibility study focussing on engraftment and hematopoietic recovery.Patients with high-risk hematological diseases, who need a allogeneicstem cell transplantation but who lack a matched unrelated donorMedDRA version: 19.0Level: PTClassification code 10061187Term: Haematopoietic neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-002383-13-NLErasmus MC
已完成
2 期
Umbilical Cord Blood Transplantation In Patients With Hematologic Malignancies Using A Myeloablative Preparative RegimenHematologic MalignanciesDisorder Related to TransplantationHematopoietic MalignancyNCT01328496St. Jude Children's Research Hospital14
进行中（未招募）
不适用
Double umbilical cord blood transplantation in high-risk hematological patients.A phase II study focussing on the mechanism of graft predominancePatients with high-risk hematological diseases, who need a allogeneic stem cell transplantation but who lack a matched unrelated donorMedDRA version: 14.1Level: PTClassification code 10061187Term: Haematopoietic neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-001188-55-BEHOVON Foundation70
招募中
2 期
Double umbilical cord blood transplantation in high-risk haematological patients. A phase II study focussing on the mechanism of graft predominanceNL-OMON39426HOVO70