Trial Search Results

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Peter L Greenberg

Collaborator: Amgen

Stanford Investigator(s):

Intervention(s):

  • Drug: Darbepoetin alfa

Phase:

Phase 1/Phase 2

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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mai Tran
6507238594
Not Recruiting