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Phase 3 Study of Recombinant Erythropoetin and Adjuvant I.V. Iron Therapy of Anemic Patients With Lymphoproliferative Disorders
This is a multi-center open label, randomized phase-3 study with stratification according to diagnosis and baseline serum-EPO level. The correction of mild or moderate anemia and the effect on iron kinetics by the rHuEPO treatment with or without intravenous iron supplementation in anemic patients with LPD not receiving antineoplastic therapy will be studied. The study will be performed according to the ICH-GCP guidelines. In order to be eligible, the patient must consent in writing that he/she agrees to participate in the study. The patient recruitment period is estimated to be no longer than 18 months.
Details
| Lead sponsor | Sundsvall Hospital |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 66 |
| Start date | 2003-12 |
| Completion | 2005-12 |
Conditions
- Anemia
- Multiple Myeloma
- Non Hodgkin Lymphoma
- Chronic Lymphocytic Leukemia
Interventions
- Neo-Recormon and Venofer
Primary outcomes
- To compare the mean change in hemoglobin (Hb) concentrations from baseline to EOT (End of treatment ) between the two treatment groups.
Countries
Sweden