ISRCTN65652441CompletedPhase 3
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 sites1,200 target enrollmentStarted: June 24, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 1,200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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