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About
The primary objectives of the trial are to assess erythroid response to darbepoetin alfa, as determined by changes in hemoglobin and/or red blood cell (RBC) transfusion-dependence and to describe the safety profile of darbepoetin alfa in patients with MDS. The secondary objective is to assess bone marrow progenitor BFU-E growth before and after treatment with darbepoetin alfa.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:- Diagnosis:
Bone marrow aspirate/biopsy-proven MDS for > 2 months prior to enrollment.
MDS French-American-British (FAB) subtypes refractory anemia (RA), RA with ringed sideroblasts (RARS), RA with excess blasts (RAEB), and non-proliferative chronic myelomonocytic leukemia (CMML) [WBC < 12,000/ml].
Patients must have an untransfused hemoglobin < 10.0 g/dL and/or patients must be red cell transfusion-dependent for a period of at least 2 months prior to study entry.
Bilirubin < or = to 2 mg/dL
ALT/SGPT < or = to 2.5 x the upper limit of normal (ULN)
Normal renal function (Stanford: serum creatinine < 1.2 mg/dL [male], < 1.0 mg/dL [female]; Vanderbilt: < 1.5 mg/dL).
ECOG performance status 0-2.
Patients may receive standard supportive care, including transfusions and antibiotics as required.
Patients must be r-HuEPO naive or must not have received prior treatment with r-HuEPO > or = to 40,000 U/week for more than 4 weeks. Exclusion Criteria:- Patients with secondary MDS or prior allogeneic bone marrow transplant.
Primary purpose
Allocation
Interventional model
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21 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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