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

• Sponsor: Peter L Greenberg (Other)
• Overall Status: Completed
• CT.gov ID: NCT00230321
• Collaborator: Amgen (Industry)
• Enrollment: 21
• Location: 1
• Arm: 1
• Duration (Months): 71
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Cancer; Myelodysplastic Syndromes; Myelodysplastic Syndromes (MDS)	Drug: Darbepoetin alfa	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• 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)
• Study Start Date: Feb 1, 2002
• Actual Primary Completion Date: Nov 1, 2007
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

2. DARBEPOETIN ALFA []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter L Greenberg, Professor Emeritus, Stanford University
• ClinicalTrials.gov Identifier: NCT00230321
• Other Study ID Numbers: HEMMDS0001; HEMMDS0001; 13536
• First Posted: Sep 30, 2005
• Last Update Posted: Feb 4, 2013
• Last Verified: Jan 1, 2013

• Additional relevant MeSH terms: Preleukemia; Hematologic Neoplasms; Myelodysplastic Syndromes; Syndrome; Darbepoetin alfa

Study Results

No Results Posted as of Feb 4, 2013