A randomised controlled trial of prolonged treatment with darbepoetin alpha (EPO), with or without recombinant human granulocyte colony stimulating factor (G-CSF), versus best supportive care in patients with low-risk myelodysplastic syndromes (MDS)

Barts and The London NHS Trust (UK)0 个研究点目标入组 1,200 人开始时间: 2010年6月24日最近更新: 2019年3月25日

适应症

试验速览

暂无简介。

•1. A confirmed diagnosis of MDS - WHO type:
•1.1. Refractory anaemia (RA)
•1.2. Hypoplastic RA ineligible for or failed immunosuppressive therapy (ALG, cyclosporine)
•1.3. Refractory anaemia with ring sideroblasts (RARS)
•1.4. Refractory cytopenia with multilineage dysplasia
•1.5. Myelodysplastic syndrome unclassifiable
•2. IPSS low or Int-1, but with BM blasts less than 5%
•3. A haemoglobin concentration of less than 10 g/dl and/or red cell transfusion dependence
•4. Written informed consent
•5. Aged more than 18 years old, no upper limit, either sex

•1. MDS with bone marrow blasts greater than or equal to 5%
•2. Myelodysplastic syndrome associated with del(5q)(q31-33) syndrome
•3. Chronic myelomonocytic leukaemia (monocytes greater than 1.0 x 10^9/l)
•4. Therapy-related MDS
•5. Splenomegaly, with spleen greater than or equal to 5 cm from left costal margin
•6. Platelets less than 30 x 10^9/l
•7. Uncorrected haematinic deficiency
•8. Age less than 18 years
•9. Woman who are pregnant or lactating
•10. Women of child bearing age unless using reliable contraception
•11. Life expectancy less than 6 months
•12. Uncontrolled hypertension, previous venous thromboembolism, or uncontrolled cardiac or pulmonary disease
•13. Previous adverse events to the study medications or its components
•14. Patients who have had previous therapy with EPO ± G-CSF within 4 weeks of study entry
•15. Patients currently receiving experimental therapy, e.g. with thalidomide, or who are participating in another clinical trial
•16. Medical or psychiatric illness, which makes the patient unsuitable or unable to give, informed consent

发起方

Barts and The London NHS Trust (UK)