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Completed

NCT Number: NCT00230321

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

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.

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Key information

Conditions

Blood Cancer Bone Marrow Diseases Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Myelodysplastic Syndromes Myelodysplastic Syndromes (MDS) Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

darbepoetin alfa

Drug

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 outcomes

  1. hemoglobin and/or red blood cell (RBC) transfusion-dependence.

  2. To assess erythroid responses to DARBEPOETIN ALFA, as determined by changes in

Secondary outcomes

  1. To assess bone marrow progenitor BFU-E growth before and after treatment

  2. DARBEPOETIN ALFA

Sponsors and collaborators

Lead sponsor

Peter L Greenberg

Other

Collaborators

  • Amgen

Registry information

Important dates

Study start
2002
Primary completion
2007
Study completion
2008
First posted
Sep 30, 2005
Registry last updated
Feb 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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