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Erythropoietin for Anemia in Lymphoma Patients Post-Transplant
NCT03010579Phase 4
Key facts
- Status
- Unknown
- Start
- Oct 2016
- Primary completion
- Dec 2017
- Countries
- 1
- Sponsor
- Peking University
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- erythropoietin
- Conditions
- anemia
01
Overview
Phase 4, randomised trial of erythropoietin in anemia (2 arms), sponsored by Peking University. Primary endpoint: Complete Hemoglobin Response Rate. Status: unknown.
02
Design
2 arms- Study design
- Randomized
erythropoietin group
Erythropoietin administered subcutaneously at 10,000 IU three times a week. Oral ferrous succinate, vitamins B12, and folic acid administered if necessary.
iron supplementation
Oral ferrous succinate, vitamins B12, and folic acid administered if necessary.
03
Who it enrols
Lymphoma patients who have undergone their first autologous hematopoietic stem cell transplantation and have a hemoglobin level less than 100 g/L on day +15 post-transplant. Excludes patients who are HIV positive, have a known allergy to recombinant human erythropoietin, or have an uncontrolled infection.
04
Endpoints
Primary
Complete Hemoglobin Response Rate
Secondary
Proportion of participants with red blood cell transfusions
Proportion of participants with deep vein thrombosis
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