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

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ClinicalTrials.gov Identifier: NCT00230321
Recruitment Status : Completed
First Posted : September 30, 2005
Last Update Posted : February 4, 2013
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Peter L Greenberg, Stanford University

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 disease Intervention/treatment Phase
Blood Cancer Myelodysplastic Syndromes Myelodysplastic Syndromes (MDS) Drug: Darbepoetin alfa Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
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 : February 2002
Actual Primary Completion Date : November 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


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.
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.




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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
    • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00230321


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Peter L Greenberg
Amgen
Investigators
Principal Investigator: Peter L Greenberg Stanford University

Responsible Party: Peter L Greenberg, Professor Emeritus, Stanford University
ClinicalTrials.gov Identifier: NCT00230321     History of Changes
Other Study ID Numbers: HEMMDS0001
HEMMDS0001
13536 ( Other Identifier: Stanford IRB )
First Posted: September 30, 2005    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Hematologic Neoplasms
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Neoplasms by Site
Darbepoetin alfa
Hematinics