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Sponsored by: |
St. Bartholomew's Hospital |
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Information provided by: | St. Bartholomew's Hospital |
ClinicalTrials.gov Identifier: | NCT00234143 |
Myelodysplastic syndromes (MDS) are acquired clonal disorders of the bone marrow. The clinical consequences of MDS are bone marrow failure and a predisposition to develop acute myeloid leukaemia (AML). Patients with 'low risk MDS' have less than 10% myeloblasts in the marrow and include the World Health Organization (WHO) subtypes refractory anaemia (RA), refractory anaemia with ring sideroblasts (RARS) and refractory anaemia with excess blasts-I (RAEB-I). This group of patients has a relatively low risk of leukaemic transformation and the major clinical problem is the manifestation of bone marrow failure. Up to 80% of these patients become red cell transfusion dependent. To date, the only curative therapy is allogeneic stem cell transplantation. Unfortunately, a median age at diagnosis of > 65 years excludes this type of therapy for most patients with MDS. The aim of treatment is, therefore, supportive therapy. Long term red cell transfusion therapy carries the problems of acute transfusion reactions: iron overload, alloantibody formation, poor venous access and the risk of transfusion transmitted infection. With time, such patients require increasing frequency of transfusion and obtain decreased length of benefit from transfusion. The quality of life of such patients is significantly reduced. Alternative therapies, therefore, aimed at promoting more effective haemopoiesis and reducing the need for red cell transfusion may improve quality of life, reduce the use of expensive resources such as red cells and iron chelation, and perhaps enhance survival.
Combined darbepoetin alfa (Aranesp) plus G-CSF (Neupogen; filgrastim) in low risk MDS is better than best supportive care, with respect to haemoglobin and quality of life. The study will assess:
Condition | Intervention | Phase |
---|---|---|
Myelodysplastic Syndromes |
Drug: darbepoetin and Neupogen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised Controlled Trial of Prolonged Treatment With Darbepoetin Alpha and Recombinant Human Granulocyte Colony Stimulating Factor (G-CSF) Versus Best Supportive Care in Patients With Low-Risk Myelodysplastic Syndromes |
Estimated Enrollment: | 300 |
Study Start Date: | October 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A confirmed diagnosis of MDS - WHO type
Exclusion Criteria:
United Kingdom | |
St Bartholomew's Hospital | |
London, United Kingdom, EC1A 7BE |
Principal Investigator: | Samir G Agrawal, MD, PhD | St. Bartholomew's Hospital |
Study ID Numbers: | 04/Q1907/94 |
Study First Received: | October 5, 2005 |
Last Updated: | May 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00234143 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
MDS Epo G-CSF |
Epoetin Alfa Myelodysplastic syndromes Preleukemia Precancerous Conditions Hematologic Diseases |
Myelodysplasia Myelodysplastic Syndromes Darbepoetin alfa Bone Marrow Diseases |
Neoplasms Pathologic Processes Disease Syndrome |