Status:
UNKNOWN
Erythropoietin (EPO) and Granulocyte-Colony Stimulating Factor (G-CSF) for Low-Risk Myelodysplastic Syndromes (MDS)
Lead Sponsor:
St. Bartholomew's Hospital
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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)...
Detailed Description
STUDY OBJECTIVES: Primary objectives: * To compare the Quality of Life of Low-risk MDS patients randomised to receive prolonged treatment with EPO alone, EPO with G-CSF or best supportive care alone...
Eligibility Criteria
Inclusion
- A confirmed diagnosis of MDS - WHO type:
- refractory anaemia (RA)
- hypoplastic RA ineligible for or failed immunosuppressive therapy (ALG, cyclosporine)
- refractory anaemia with ring sideroblasts (RARS)
- refractory cytopenia with multilineage dysplasia
- myelodysplastic syndrome unclassifiable
- IPSS low or Int-1, but with BM blasts \<5%
- A haemoglobin concentration of \< 10g/dl and/or red cell transfusion dependence
- Written informed consent.
Exclusion
- MDS with bone marrow blasts ≥5%
- Myelodysplastic syndrome associated with del(5q)(q31-33) syndrome
- Chronic myelomonocytic leukaemia (monocytes \>1.0x109/l)
- therapy-related MDS
- Splenomegaly, with spleen ≥ 5 cm from left costal margin
- Platelets \<30x109/l
- Uncorrected haematinic deficiency
- Age less than 18 years
- Woman who are pregnant or lactating
- Women of child bearing age unless using reliable contraception
- Life expectancy \< 6 months
- Uncontrolled hypertension, previous venous thromboembolism, or uncontrolled cardiac or pulmonary disease
- Previous adverse events to the study medications or its components
- Patients who have had previous therapy with EPO ± G-CSF within 4 weeks of study entry
- Patients currently receiving experimental therapy, e.g. with thalidomide, or who are participating in another clinical trial
- Medical or psychiatric illness, which makes the patient unsuitable or unable to give, informed consent.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00234143
Start Date
October 1 2004
Last Update
March 12 2009
Active Locations (1)
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1
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE