A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)
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.
Arms and Interventions
|Experimental: Darbepoetin alfa|
During the induction phase, the investigational agent DARBEPOETIN ALFA will be initiated at a dose of 4.5 ug/kg/week subcutaneously for 6 weeks. The dosage for the remaining treatment is dependent of patients response during the induction phase.
Drug: Darbepoetin alfa
During the induction phase, the investigational agent DARBEPOETIN ALFA will be initiated at a dose of 4.5 ug/kg/week subcutaneously.If patients do not achieve a major erythroid response by 6 weeks, the dose of DARBEPOETIN ALFA will be doubled to 9.0 ug/kg/week.
Primary Outcome Measures
- hemoglobin and/or red blood cell (RBC) transfusion-dependence. 
- To assess erythroid responses to DARBEPOETIN ALFA, as determined by changes in 
Secondary Outcome Measures
- To assess bone marrow progenitor BFU-E growth before and after treatment 
- DARBEPOETIN ALFA 
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).
Age: > or = to 18
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.
Contacts and Locations
|1||Stanford University School of Medicine||Stanford||California||United States||94305|
Sponsors and Collaborators
- Peter L Greenberg
- Principal Investigator: Peter L Greenberg, Stanford University
Study Documents (Full-Text)None provided.