A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)
Trial ID or NCT#
NCT00230321
Status
NOT RECRUITING
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.
Official Title
A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
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.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Mai Tran
6507238594
View on ClinicalTrials.gov
