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

NCT00230321 | Completed Phase 1

• 3 other identifiers: HEMMDS0001NCT0023032113536
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Cancer; Myelodysplastic Syndromes; Myelodysplastic Syndromes (MDS)

Outcome Measures

Primary Outcomes (2)

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

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

Secondary Outcomes (2)

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

• DARBEPOETIN ALFA

Study Arms (1)

Darbepoetin alfa

EXPERIMENTAL

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

Interventions

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.

Darbepoetin alfa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Peter L Greenberg: lead
• Amgen: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Myelodysplastic Syndromes

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Peter L Greenberg

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Emeritus

Study Record Dates

• First Submitted: September 28, 2005
• First Posted: September 30, 2005
• Study Start: February 1, 2002
• Primary Completion: November 1, 2007
• Study Completion: January 1, 2008
• Last Updated: February 4, 2013

Record last verified: 2013-01

Locations

US (1)