Darbepoetin Alpha in Myelodysplastic Syndromes (MDS)

• Status: Unknown status
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an evaluation of the effectiveness of darbepoetin alpha in treating anemia of MDS patients with an International Prognostic Scoring System (IPSS) score of low or intermediate 1.

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

Details

• Lead Sponsor: Groupe Francophone des Myelodysplasies
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• MDS of the following subtypes:

• RA, RAS, RAEB with marrow blasts < 10% (according to FAB),

• RA, RARS, RCMD, RAEB 1, CMML 1 with ≤ 10% WBC counts < 13000/mm3 (according to WHO classification)

• Anemia, defined by Hb < 10 g/dl or RBC transfusion requirement in the absence of other causes of anemia (especially renal failure, iron, or folate deficiency)

• IPSS ≤ 1(ie IPSS low or intermediate 1)

• EPO level < 500 UI/L

• Ability to perform physical tests of exercise tolerance

• No renal failure (creatinine ≤ 120% normal upper value for the center)

• No underlying severe condition

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

• Must be 18 years of age or older at the time of screening

• Written informed consent

Exclusion Criteria:

• Therapy related MDS

• MDS with IPSS > 1 (int 2 or high score)

• Chronic myelomonocytic leukemia with > 10% marrow blasts or WBC > 13000/mm3

• Uncontrolled systemic hypertension

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

• Creatinine level > 120% upper normal value for the center.

• Clinically significant systemic infection or chronic inflammatory disease (eg, rheumatoid arthritis) present at the time of screening

• Serum folate ≤ 2.0 ng/mL or vitamin B12 ≤ 200 pg/mL (anemia related to nutritional deficiencies)

• Other causes of anemia (eg, hemolysis, bleeding, sickle cell anemia, renal disease)

• Pregnant (ie, positive βhCG test) or breast feeding female subjects

• Women of childbearing potential and not using adequate contraceptives

• Known positive antibody response to an erythropoietic growth factor

• Known hypersensitivity to darbepoetin alpha or any of its excipients, or to recombinant erythropoietins

• Patient unable to understand the protocol or to be adequately followed up.

• History of seizures

• Previous history of thrombotic events

• Concomitant treatment with thalidomide