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

Peter L Greenberg

Status and phase: Completed; Phase 2; Phase 1

Conditions: Blood Cancer; Myelodysplastic Syndromes (MDS); Myelodysplastic Syndromes

Treatments: Drug: Darbepoetin alfa

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00230321

13536 (Other Identifier)

HEMMDS0001

NCT00230321

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Darbepoetin alfa

Experimental group

Description:

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.

Treatment:

Drug: Darbepoetin alfa