Transfusion Effects of Myelodysplastic Patients: Limiting Exposure

Sanquin Blood Bank South West Region (The Netherlands)0 个研究点目标入组 200 人开始时间: 2005年12月20日最近更新: 2017年10月16日

适应症

试验速览

暂无简介。

•1. Diagnosis myelodysplastic syndrome (primary or secondary) based on cytopenia in at least 1 cell line and dysplasia in 2 cell lines (and no other cause [especially deficiencies]) and a pathologic anatomic diagnosis after bone marrow punction
•2. Refractory Anaemia (RA):
•2.1. Blood: less than or equal to 1% blasts, less than or equal to 1 x 10^9 monocytes
•2.2. Bone marrow: less than 5% blasts, ringed sideroblasts less than or equal to 15% of the erythroid cells
•3. Refractory Anaemia with Ringed Sideroblasts (RARS):
•3.1. Blood: less than or equal to 1% blasts, less than or equal to 1 x 10^9 monocytes
•3.2. Bone marrow: less than 5% blasts, ringed sideroblasts greater than 15% of the erythroid cells
•4. Refractory Anaemia with Excess Blasts (RAEB):
•4.1. Blood: less than 5% blasts, less than or equal to 1 x 10^9 monocytes
•4.2. Bone marrow: blasts greater than or equal to 5% to less than or equal to 20%
•5. Chronic Myelomonocytic Leukaemia (CMML):
•5.1. Blood: greater than 1 x 10^9/l monocytes, less than 5% blasts
•5.2. Bone marrow: blasts less than 20%, increase of the monocytic component
•6. Erythrocyte transfusion need
•7. Working knowledge of the national language
•8. Written consent for participating this study (informed consent)

•1. Candidate for bone marrow or organ transplantation
•2. Medication: growth factors (Granulocyte Monocyte Colony Stimulating Factor [GM-CSF]), or Erythropoietin (EPO)
•3. Patients who will receive an intensive chemotherapeutic treatment with a cytopenia, expected longer than 2 weeks
•4. Refractory anaemia with excess blasts in transformation (RAEB-t):
•4.1. Blood: 5% blasts or Auer rods
•4.2. Bone marrow: or blasts greater than 20% to less than 30% or Auer rods
•5. Pregnancy at the moment of inclusion
•6. Patients with congenital severe haemolytic anaemia, like thalassemia or sickle cell anaemia
•7. Patients with Acquired Immune Deficiency Syndrome (AIDS) or a severe congenital or acquired (e.g., iatrogenic) immunological disorder
•8. Severe active infections at the moment of inclusion
•9. Severe cardiac, pulmonal, neurological, metabolic or psychiatric disease at the moment of inclusion

发起方

Sanquin Blood Bank South West Region (The Netherlands)