Prospective, Multicenter, Open Label and Single-arm Study of Darbepoetin Alfa for Anemia in Myelodisplastic Syndrome Patients.

• Status: Terminated
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, single-arm, multicentre, prospective study of darbepoetin alfa to treat anaemia in patients with low and intermediate-1 IPSS risk MDS. The study will consist of a 14-day screening period followed by a maximum 24-week treatment period and a final visit.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• Age ³ 18 years

• Low or intermediate-1 risk MDS according to IPSS, and FAB classification of RA, RARS, or RAEB with blasts £ 10%

• Predictive variables of good response (serum erythropoietin levels < 500 IU/l and transfusion requirements < 2 packed RBC/month over the preceding 2 months)

• Anaemia (Hb £ 10 g/dL), confirmed in the 14 days before day 1 of the study

• Life expectancy of at least 6 months

• ECOG Performance status score of 0, 1, or 2

• Subject must sign and date the Informed Consent (approved by a Clinical Research Ethics Committee - CREC), before any study-specific procedure is performed

Exclusion Criteria:

• Known history of convulsive disorders

• Poorly controlled hypertension (diastolic blood pressure > 100 mmHg) at screening

• Inadequate liver function (total bilirubin > two times the upper limit of the normal range (ULN), and liver enzymes (ALT, AST) > two times ULN)

• Inadequate renal function (serum creatinine concentration > 2 mg/dL)

• Ferritin < 100 ng/ml or transferrin saturation index (TSI) < 16%; Vitamin B12 deficiency (< 200 pg/ml) or folate deficiency (< 2 ng/ml)

• Clinically-relevant haemorrhages

• Haemolytic anaemia

• Cardiac condition: uncontrolled angina, congestive heart failure, or uncontrolled cardiac arrhythmia

• Clinically significant systemic infection or chronic inflammatory disease present at time of screening

• Any concomitant therapy used to treat MDS (including other growth factors than those described as part of this protocol, chemotherapy, antibody-based cancer treatment, hormonal therapy, interferon, and interleukins)

• Treatment with rHuEPO or darbepoetin alfa over the 4 weeks prior to Day 1 of the study

• More than 2 RBC transfusions over the 28 days prior to Day 1 of the study

• Pregnant or breast feeding women

• Subjects of childbearing-potential who do not take adequate contraceptive measures, in the opinion of the investigator

• Known hypersensitivity to any mammal-derived recombinant product