A Phase 1/2 interventional study of Darbepoetin alfa in Blood Cancer, Myelodysplastic Syndromes and Myelodysplastic Syndromes (MDS), sponsored by Peter L Greenberg. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-04.
Sponsored by Peter L Greenberg · Phase 1/2, Interventional, and Treatment
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.
1,317 studies on the registry are indexed under Preleukemia; 57 are open to participants now.
This study's enrollment of 21 is below the median of 36 across 1,060 interventional studies indexed under Preleukemia.
Browse Preleukemia studies →Peter L Greenberg is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:- Diagnosis:
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.
Normal renal function (Stanford: serum creatinine \< 1.2 mg/dL [male], \< 1.0 mg/dL [female]; Vanderbilt: \< 1.5 mg/dL).
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.
hemoglobin and/or red blood cell (RBC) transfusion-dependence.
To assess erythroid responses to DARBEPOETIN ALFA, as determined by changes in
To assess bone marrow progenitor BFU-E growth before and after treatment
DARBEPOETIN ALFA
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Peter L Greenberg