REGiM: Prolonged treatment with darbepoetin alpha (EPO), with/without recombinant human granulocyte colony stimulating factor (G-CSF), versus best supportive care in patients with low-risk myelodysplastic syndromes (MDS)

Phase 3

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Haematological Oncology; Disease: Leukaemia (acute myeloid); Cancer; Myelodysplastic syndromes

• Registration Number: ISRCTN65652441
• Lead Sponsor: Barts and The London NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-12-11
• Study Start: 2010-06-24
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life at 24 weeks

Secondary Outcome Measures

Name	Time	Method
<br> 1. Quality of life at 12, 36 and 52 weeks<br> 2. Overall erythroid response (major and minor) at 24 weeks (main analysis point) and also at 12 and 52 weeks, as defined by the International Working Group criteria<br> 3. Incidence of disease progression<br> 4. Overall survival<br> 5. Economic costs of managing anaemia in each arm of the study<br>