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

Myelodysplastic Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230321
• Other study ID #: HEMMDS0001
• Secondary ID: HEMMDS000113536
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 28, 2005
• Last updated: January 31, 2013
• Start date: February 2002
• Est. completion date: January 2008

Study information

• Verified date: January 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Cancer
• Hematologic Neoplasms
• Myelodysplastic Syndromes
• Myelodysplastic Syndromes (MDS)
• Preleukemia
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Peter L Greenberg	Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin and/or red blood cell (RBC) transfusion-dependence.		unknown	No
Primary	To assess erythroid responses to DARBEPOETIN ALFA, as determined by changes in		unknown	No
Secondary	To assess bone marrow progenitor BFU-E growth before and after treatment		unknown	No
Secondary	DARBEPOETIN ALFA		unknown	No