A Phase 2 Study to Evaluate the Safety and Effectiveness of Once Weekly or Once Every Two Week Dosing of Epoetin Alfa in Anemic Patients With Low- or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)

• Status: Withdrawn
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness of PROCRIT (Epoetin alfa) 80,000 Units given once weekly or 80,000 Units given once every two weeks in anemic patients with Low- or Intermediate-1 risk Myelodysplastic Syndromes (MDS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho Biotech Clinical Affairs, L.L.C.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Diagnosis of Myelodysplastic Syndromes (MDS) via bone marrow aspirate and biopsy according to World Health Organization (WHO) Criteria or French-American-British (FAB) Classification. All WHO and FAB subtypes of MDS are potentially eligible, provided the subject's International Prognostic Scoring System (IPSS) score is Low- or Intermediate-1 [with the exception of chronic myelomonocytic leukemia (CMML)]

• Documentation of IPSS score of Low- or Intermediate-1 risk disease (<= 10% bone marrow blasts), based on bone marrow aspirate, biopsy, and cytogenetics, within 12 weeks prior to study entry

• Baseline hemoglobin (Hb) value of <10 g/dL [defined as the average of at least 2 measurements [(not influenced by red blood cell (RBC) transfusions for at least 1 week) >= 1 week apart]. The Hb level prior to the first dose of PROCRIT (Epoetin alfa) cannot be > 10.5 g/dL.

Exclusion Criteria:

• No anemia due to factors other than MDS (including hemolysis or gastrointestinal bleeding)

• No proliferative (White Blood Cells (WBC) >= 12,000/mm3) chronic myelomonocytic leukemia (CMML)

• No history of (within 12 months) deep venous thrombosis [(DVT), includes proximal and distal], pulmonary embolism (PE), or other venous thrombosis. Prior superficial thrombophlebitis is not an exclusion criterion

• No history of (within 6 months) cerebrovascular accident [(CVA), includes ischemic, embolic and hemorrhagic], transient ischemic attack (TIA), myocardial ischemia [includes Unstable Angina, Q wave Myocardial Infarction (QwMI) and non-Q wave Myocardial Infarction (NQMI)], or other arterial thrombosis

• No prior Erythropoietin Receptor Agonist (ERA) treatment within 4 weeks prior to the first study dose

• No prior ERA treatment failure (defined as having shown no Hb response or a Hb response <1 g/dL after at least 6 weeks of ERA treatment) with minimum dose of Epoetin alfa 40,000 Units/week or Darbepoetin alfa 150 mcg/ week.