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A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes

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Trial Information

A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome

Inclusion Criteria


Eligibility Criteria: General: - Low risk MDS (low or intermediate-1 risk as defined by
IPSS) and FAB classification of RA, RARS, or RAEB with blasts less than or equal to 10%
determined via a bone marrow biopsy and CBC - Adequate iron stores determined by bone
marrow film or section staining for iron via a bone marrow biopsy - ECOG Performance
status score of 0, 1, or 2 Laboratory: - Local laboratory screening Hgb less than or equal
to 11.0g/dL - Adequate renal function (serum creatinine concentration less than or equal
to 2.0 mg/dL) - Adequate liver function (total bilirubin less than or equal to 2 times,
ALT less than or equal to 3 times, and AST less than or equal to 3 times the upper limit
of the respective normal range) Ethical: - Must be 18 years of age or older - Provide
written Institutional Review Board (IRB)-approved informed consent before any screening
procedures are performed

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The proportion of subjects achieving an erythroid response during the 13-week test period

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20030207

NCT ID:

NCT00095264

Start Date:

October 2004

Completion Date:

Related Keywords:

  • Myelodysplastic Syndromes
  • Myelodysplastic Syndrome
  • Myelodysplastic Syndromes
  • Preleukemia

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