We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00230321
First Posted: September 30, 2005
Last Update Posted: February 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Amgen
Information provided by (Responsible Party):
Peter L Greenberg, Stanford University
  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
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)

Resource links provided by NLM:


Further study details as provided by Peter L Greenberg, Stanford University:

Primary Outcome Measures:
  • hemoglobin and/or red blood cell (RBC) transfusion-dependence.
  • To assess erythroid responses to DARBEPOETIN ALFA, as determined by changes in

Secondary Outcome Measures:
  • To assess bone marrow progenitor BFU-E growth before and after treatment
  • DARBEPOETIN ALFA

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

  Contacts and Locations
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
  More Information

Responsible Party: Peter L Greenberg, Professor Emeritus, Stanford University
ClinicalTrials.gov Identifier: NCT00230321     History of Changes
Other Study ID Numbers: HEMMDS0001
13536 ( Other Identifier: Stanford IRB )
First Submitted: September 28, 2005
First Posted: September 30, 2005
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