Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Myelodysplastic Syndrome

Thank you

Trial Information

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

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. Darbepoetin alfa will be initiated at a dose of 300 mcg QW SC over a period of 8
weeks. After 8 weeks, erythroid response will be evaluated, and treatment algorithm adapted
to it.

The study treatment period will last for a maximum of 24 weeks. The treatment will end at
the start of week 24. If the scheduled 24-week treatment period is not completed, it will
end during the week of the last administration of the study drug.

The follow-up period will last for a minimum of 4 weeks and a maximum of 8 weeks after the
last dose of darbepoetin alfa.

Subjects will be stratified at enrolment according to IPSS (low risk versus intermediate-1

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients achieving an erythroid response during the 24-week treatment period.

Outcome Time Frame:

weeks 8; 12; 16 and 24

Safety Issue:


Principal Investigator

Ana M Villegas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

February 2006

Completion Date:

July 2009

Related Keywords:

  • Myelodysplastic Syndrome
  • Myelodysplastic syndrome
  • Myelodysplastic Syndromes
  • Preleukemia