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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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: February 2002
Study Completion Date: January 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Peter L Greenberg, Professor Emeritus, Stanford University
ClinicalTrials.gov Identifier: NCT00230321     History of Changes
Other Study ID Numbers: HEMMDS0001, HEMMDS0001, 13536
Study First Received: September 28, 2005
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Hematologic Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
 Neoplasms by Site
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013