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

Phase 1

Completed

• Conditions: Blood Cancer; Myelodysplastic Syndromes; Myelodysplastic Syndromes (MDS)
• Interventions: Drug: Darbepoetin alfa

• Registration Number: NCT00230321
• Lead Sponsor: Peter L Greenberg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2005-09-28
• Study First Submitted QC: 2005-09-28
• Study First Posted: 2005-09-30
• Primary Completion: 2007-11
• Study Completion: 2008-01
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-31
• Last Update Posted: 2013-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Darbepoetin alfa	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.

Primary Outcome Measures

Name	Time	Method
hemoglobin and/or red blood cell (RBC) transfusion-dependence.
To assess erythroid responses to DARBEPOETIN ALFA, as determined by changes in

Secondary Outcome Measures

Name	Time	Method
To assess bone marrow progenitor BFU-E growth before and after treatment
DARBEPOETIN ALFA

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States