REGIME: A Randomised Controlled Trial of Prolonged Treatment With Darbepoetin Alpha, With or Without Recombinant Human Granulocyte Colony Stimulating Factor, Versus Best Supportive Care in Patients With Low-risk Myelodysplastic Syndromes (MDS).
1. Males and females aged over 18 years, (no upper age limit)
2. ECOG performance status 0-2
3. Life expectancy more than 6 months
4. A confirmed diagnosis of MDS - WHO type:
- refractory anaemia (RA)
- hypoplastic RA ineligible for/or failed immunosuppressive therapy (ALG,
- refractory anaemia with ring sideroblasts (RARS)
- refractory cytopenia with multilineage dysplasia
- myelodysplastic syndrome unclassifiable
5. IPSS low or Int-1, but with BM blasts less than 5%
6. A haemoglobin concentration of less than 10g/dl and/or red cell transfusion
7. Able to understand the implications of participation in the Trial and give written
1. MDS with bone marrow blasts greater or equal than 5%
2. Myelodysplastic syndrome associated with del(5q)(q31-33) syndrome
3. Chronic myelomonocytic leukaemia (monocytes greater than1.0x109/l)
4. Therapy-related MDS
5. Splenomegaly, with spleen greater or equal than 5 cm from left costal margin
6. Platelets less than 30x109/l
7. Uncorrected haematinic deficiency. Patient deplete to iron, B12 and folate according
to local lab ranges
8. Women who are pregnant or lactating.
9. Females of childbearing potential and all males must be willing to use an effective
method of contraception (hormonal or barrier method of birth control; abstinence) for
the duration of the study and for up to 3 months after the last dose of study
medication. Note: Subjects are not considered of child bearing potential if they are
surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or
bilateral oophorectomy) or they are postmenopausal
10. Females of childbearing potential must have a negative pregnancy test prior to
starting the study.
11. Uncontrolled hypertension, previous venous thromboembolism, or uncontrolled cardiac
or pulmonary disease
12. Previous serious adverse events to the study medications or its components
13. Patients who have had previous therapy with ESAs ± G-CSF within 4 weeks of study
14. Patients currently receiving experimental therapy, e.g. with thalidomide, or who are
participating in another CTIMP.
15. Medical or psychiatric illness, which makes the patient unsuitable or unable to give
16. Patients with malignancy requiring active treatment (except hormonal therapy).
17. Patients with a history of seizures