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

Sponsor
Peter L Greenberg (Other)
Overall Status
Completed
CT.gov ID
NCT00230321
Collaborator
Amgen (Industry)
21
Enrollment
1
Location
1
Arm
71
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Darbepoetin alfa
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)
Study Start Date :
Feb 1, 2002
Actual Primary Completion Date :
Nov 1, 2007
Actual Study Completion Date :
Jan 1, 2008

Arms and Interventions

ArmIntervention/Treatment
Experimental: 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.

Drug: Darbepoetin alfa
During the induction phase, the investigational agent DARBEPOETIN ALFA will be initiated at a dose of 4.5 ug/kg/week subcutaneously.If patients do not achieve a major erythroid response by 6 weeks, the dose of DARBEPOETIN ALFA will be doubled to 9.0 ug/kg/week.

Outcome Measures

Primary Outcome Measures

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

  2. To assess erythroid responses to DARBEPOETIN ALFA, as determined by changes in []

Secondary Outcome Measures

  1. To assess bone marrow progenitor BFU-E growth before and after treatment []

  2. DARBEPOETIN ALFA []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Stanford University School of MedicineStanfordCaliforniaUnited States94305

Sponsors and Collaborators

  • Peter L Greenberg
  • Amgen

Investigators

  • Principal Investigator: Peter L Greenberg, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peter L Greenberg, Professor Emeritus, Stanford University
ClinicalTrials.gov Identifier:
NCT00230321
Other Study ID Numbers:
  • HEMMDS0001
  • HEMMDS0001
  • 13536
First Posted:
Sep 30, 2005
Last Update Posted:
Feb 4, 2013
Last Verified:
Jan 1, 2013

Study Results

No Results Posted as of Feb 4, 2013