ISRCTN65652441
Completed
Phase 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 enrollmentJune 24, 2010
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Topic: National Cancer Research Network
- Sponsor
- Barts and The London NHS Trust (UK)
- Enrollment
- 1200
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
ong-term follow-up of breast cancer survivors: A randomized controlled studyBreast cancer survivorshipCancerBreast cancerISRCTN15403211Koo Foundation Sun Yat-Sen Cancer Center902
Completed
Phase 2
Randomized controlled trial of effects of long-term consumption of milk and dairy products in addition to dietary guidance on metabolic syndromeMetabolic SyndromeJPRN-UMIN000006353Japan Dairy Association200
Completed
Not Applicable
Randomised controlled trial on long- term sound therapy using predictable and unpredictable sounds in adults with constant tinnitusTinnitusEar - Other ear disordersACTRN12616000742471Mithila Durai25
Active, not recruiting
Not Applicable
A trial comparing short course antibiotics and standard course antibiotics for the treatment of sepsisSepsisInfections and InfestationsISRCTN40090372ewcastle upon Tyne Hospitals NHS Foundation Trust2,244
Recruiting
Not Applicable
ifestyle Intervention Study for Dementia Risk Reduction in Healthy Adults Aged Over 50 Years - The LEISURE studyDementiaNeurological - DementiasACTRN12620000054910niversity of the Sunshine Coast500