Status:
COMPLETED
A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)
Lead Sponsor:
Peter L Greenberg
Collaborating Sponsors:
Amgen
Conditions:
Blood Cancer
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- Patients with secondary MDS or prior allogeneic bone marrow transplant.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00230321
Start Date
February 1 2002
End Date
January 1 2008
Last Update
February 4 2013
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305