Erythropoietin in the Treatment of Anemia After Autologous Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Erythropoietin in the Treatment of Anemia in Patients With Lymphoma After Autologous Hematopoietic Stem Cell Transplantation

Conditions
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Anemia, Lymphoma, Hematopoietic Stem Cell Transplantation

Intervention / Treatment
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* Drug: erythropoietin
* Drug: iron supplementation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: erythropoietin group<br>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. | Drug: erythropoietin<br>* Erythropoietin will be administered subcutaneously (s.c.) at the dose of 10 000 IU, three times a week. If necessary,oral ferrous succinate vitamins B12 and folic acid will be administered.<br>* Other names: Erythropoiesis-Stimulating Agent;|
| Active Comparator: iron supplementation<br>If necessary，oral ferrous succinate, vitamins B12 and folic acid will be administered. | Drug: iron supplementation<br>* If necessary, oral ferrous succinate, vitamins B12 and folic acid will be administered.<br>* Other names: ferrous succinate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete hemoglobin response rate | proportion of complete correctors (reaching hemoglobin 120 g/L in male patients, 110 g/L in female patients) before day +60 post-transplant | from day +15 to day +60 after autologous hematopoietic stem cell transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of participants with red blood cell transfusions | proportion of participants with red blood cell transfusions from day +15 to day +60 post-transplant | from day +15 to day +60 after autologous hematopoietic stem cell transplantation | 
| proportion of participants with deep vein thrombosis | proportion of participants with deep vein thrombosis from day +15 to day +60 post-transplant | from day +15 to day +60 after autologous hematopoietic stem cell transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Lymphoma, Hematopoietic stem cell transplantation, Erythropoietin