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

Phase 1/Phase 2
18 Years
Not Enrolling
Blood Cancer, Myelodysplastic Syndromes, Myelodysplastic Syndromes (MDS)

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

hemoglobin and/or red blood cell (RBC) transfusion-dependence.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Peter L Greenberg

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

February 2002

Completion Date:

January 2008

Related Keywords:

  • Blood Cancer
  • Myelodysplastic Syndromes
  • Myelodysplastic Syndromes (MDS)
  • Myelodysplastic Syndromes
  • Preleukemia
  • Hematologic Neoplasms



Stanford University School of Medicine Stanford, California  94305-5317