A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)

Not Recruiting

Trial ID: NCT00230321


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)


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.


drug: Darbepoetin alfa

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mai Tran

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