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

Peter L Greenberg1 site in 1 country21 target enrollmentFebruary 2002

ConditionsBlood Cancer Myelodysplastic Syndromes Myelodysplastic Syndromes (MDS)

InterventionsDarbepoetin alfa

DrugsDarbepoetin alfa

Overview

Phase: Phase 1
Intervention: Darbepoetin alfa
Conditions: Blood Cancer
Sponsor: Peter L Greenberg
Enrollment: 21
Locations: 1
Primary Endpoint: hemoglobin and/or red blood cell (RBC) transfusion-dependence.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

February 2002

End Date

January 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peter L Greenberg

Responsible Party

Sponsor Investigator

Principal Investigator

Peter L Greenberg

Professor Emeritus

Stanford University

Eligibility Criteria

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
•ECOG performance status 0-

Exclusion Criteria

•Patients with secondary MDS or prior allogeneic bone marrow transplant.

Arms & Interventions

Darbepoetin alfa

During the induction phase, the investigational agent DARBEPOETIN ALFA will be initiated at a dose of 4.5 ug/kg/week subcutaneously for 6 weeks. The dosage for the remaining treatment is dependent of patients response during the induction phase.

Intervention: Darbepoetin alfa