Efficacy and Safety of Erythropoietin in the Treatment of Anemia in Patients With Lymphoma After Autologous Hematopoietic Stem Cell Transplantation
Overview
- Phase
- Phase 4
- Intervention
- erythropoietin
- Conditions
- Anemia
- Sponsor
- Peking University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- complete hemoglobin response rate
- Last Updated
- 9 years ago
Overview
Brief Summary
This is an randomized trial to evaluate the potential benefit of erythropoietin in the treatment of anemia in patients with lymphoma after autologous hematopoietic stem cell transplantation.
Detailed Description
Lymphoma patients with anemia on day +15 post-transplant will be randomized to erythropoietin group or control group. Potential benefit of erythropoietin will be evaluatedon day +60 post-transplant.
Investigators
Jun Zhu
Chairman of Lymphoma Department
Peking University
Eligibility Criteria
Inclusion Criteria
- •confirmed lymphoma
- •first autologous hematopoietic stem cell transplantation
- •hemoglobin level less than 100 g/L on day +15 post-transplant
- •written informed consent given by patient or his/her guardian if of minor age.
Exclusion Criteria
- •HIV positive
- •Known allergy to recombinant human erythropoietin
- •Uncontrolled infection
Arms & Interventions
erythropoietin group
For those lymphoma patients with hemoglobin level less than 100 g/L on day +15 after autologous hematopoietic stem cell transplantation, erythropoietin will be administered. If necessary,oral ferrous succinate vitamins B12 and folic acid will be administered.
Intervention: erythropoietin
iron supplementation
If necessary，oral ferrous succinate, vitamins B12 and folic acid will be administered.
Intervention: iron supplementation
Outcomes
Primary Outcomes
complete hemoglobin response rate
Time Frame: from day +15 to day +60 after autologous hematopoietic stem cell transplantation
proportion of complete correctors (reaching hemoglobin 120 g/L in male patients, 110 g/L in female patients) before day +60 post-transplant
Secondary Outcomes
- proportion of participants with red blood cell transfusions(from day +15 to day +60 after autologous hematopoietic stem cell transplantation)
- proportion of participants with deep vein thrombosis(from day +15 to day +60 after autologous hematopoietic stem cell transplantation)