- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00230321
A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)
January 31, 2013 updated by: Peter L Greenberg
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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hemoglobin and/or red blood cell (RBC) transfusion-dependence.
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To assess erythroid responses to DARBEPOETIN ALFA, as determined by changes in
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Secondary Outcome Measures
Outcome Measure |
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To assess bone marrow progenitor BFU-E growth before and after treatment
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DARBEPOETIN ALFA
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter L Greenberg, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2002
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
September 28, 2005
First Submitted That Met QC Criteria
September 28, 2005
First Posted (Estimate)
September 30, 2005
Study Record Updates
Last Update Posted (Estimate)
February 4, 2013
Last Update Submitted That Met QC Criteria
January 31, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEMMDS0001
- NCT00230321
- 13536 (Other Identifier: Stanford IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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