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

This study has been completed.

Sponsor:

Collaborator:

Amgen

Information provided by (Responsible Party):

Peter L Greenberg, Stanford University

ClinicalTrials.gov Identifier:

NCT00230321

First received: September 28, 2005

Last updated: January 31, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 28, 2005

Last Updated Date

January 31, 2013

Start Date ^ICMJE

February 2002

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

hemoglobin and/or red blood cell (RBC) transfusion-dependence. [ Time Frame: unknown ] [ Designated as safety issue: No ]
To assess erythroid responses to DARBEPOETIN ALFA, as determined by changes in [ Time Frame: unknown ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00230321 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess bone marrow progenitor BFU-E growth before and after treatment [ Time Frame: unknown ] [ Designated as safety issue: No ]
DARBEPOETIN ALFA [ Time Frame: unknown ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Blood Cancer
Myelodysplastic Syndromes
Myelodysplastic Syndromes (MDS)

Intervention ^ICMJE

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.

Study Arm (s)

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.

Intervention: Drug: Darbepoetin alfa

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2008

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00230321

Other Study ID Numbers ^ICMJE

HEMMDS0001, HEMMDS0001, 13536

Has Data Monitoring Committee

Not Provided

Responsible Party

Peter L Greenberg, Stanford University

Study Sponsor ^ICMJE

Peter L Greenberg

Collaborators ^ICMJE

Amgen

Investigators ^ICMJE

Principal Investigator:

Peter L Greenberg

Stanford University

Information Provided By

Stanford University

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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