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A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)
Not Recruiting
Trial ID: NCT00230321
Purpose
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.
Official Title
A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)
Stanford Investigator(s)
Jason Gotlib
Professor of Medicine (Hematology)
Eligibility
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.
- Laboratory:
* 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
* Other:
* 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.
Intervention(s):
drug: Darbepoetin alfa
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mai Tran
6507238594