ISRCTN90484310进行中（未招募）未知
A multi-centre open randomised controlled trial to assess the effect of related haplo-donor haematopoietic stem cell transplantation versus standard of care (no transplant) on treatment failure at 24 month in adults with severe sickle cell disease (REDRESS V1.0)
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- 性别
- All
入选标准
- •1. Adult patients aged > = 18 years
- •2. Confirmed haploidentical donor
- •3. Severe SCD phenotype who are at high risk for morbidity and mortality. Severe SCD is defined by at least one of the following:
- •3.1. Clinically significant neurologic event (stroke) or deficit lasting > 24 hours
- •3.2. History of > = 2 acute chest syndromes in a 2-year period preceding enrolment despite optimum treatment, e.g. with hydroxycarbamide (HC)
- •3.3. History of > = 3 severe pain crises per year in a 2-year period preceding enrolment despite the institution of supportive care measures (e.g. optimum treatment with HC)
- •3.4. Administration of regular transfusion therapy (=8 packed red blood transfusions per year for 1 year to prevent vaso-occlusive complications).
- •3.5. Patients assessed as requiring transfusion but with red cell alloantibodies/very rare blood type, rendering it difficult to continue/commence chronic transfusion
- •3.6. Patients requiring HC/transfusion for treatment of SCD complications who cannot tolerate either therapy due to significant adverse reactions
- •3.7. Established end organ damage relating to SCD, including but not limited to progressive sickle vasculopathy and hepatopathy. End-organ sufficient for entry to this trial shall be ratified at the UK NHP.
- •4. Patients must be fit to proceed to Haploidentical SCT as defined below:
- •4.1. Karnofsky score > = 60
- •4.2. Cardiac function: LVEF > = 45% or shortening fraction > = 25%
- •4.3. Lung Function: FEV1, FVC and TLCO > = 50%
- •4.4. Renal function: EDTA GFR > = 40 ml/m2/1.73m2
- •4.5. Hepatic function: ALT < x3 ULN and bilirubin < x2 the upper limit of normal, those with hyperbilirubinemia due to sickle-related haemolysis will not be excluded. No radiological evidence of cirrhosis.
- •5. Written informed consent
排除标准
- •1. Fully matched sibling donor.
- •2. Previous bone marrow transplant.
- •3. Pregnancy or breast feeding.
- •4. Participants who are able to conceive a child and are unprepared to use effective contraception.
- •5. Clinically significant donor-specific HLA antibodies.
- •6. HIV infection or active Hepatitis B or C.
- •7. Uncontrolled infection including bacterial, fungal and viral.
- •8. Participation in another interventional trial in the last three months.
- •9. Pre-existing condition deemed to significantly increase the risk of Haploidentical SCT by the local Principal Investigator.
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