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

Phase 4

• Conditions: Anemia; Lymphoma; Hematopoietic Stem Cell Transplantation
• Interventions: Drug: iron supplementation; Drug: erythropoietin

• Registration Number: NCT03010579
• Lead Sponsor: Peking University

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-12-29
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-03
• Last Update Submitted: 2017-01-03
• Study First Posted: 2017-01-05
• Last Update Posted: 2017-01-05
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iron supplementation	iron supplementation	If necessary，oral ferrous succinate, vitamins B12 and folic acid will be administered.
erythropoietin group	erythropoietin	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.

Primary Outcome Measures

Name	Time	Method
complete hemoglobin response rate	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 Outcome Measures

Name	Time	Method
proportion of participants with red blood cell transfusions	from day +15 to day +60 after autologous hematopoietic stem cell transplantation	proportion of participants with red blood cell transfusions from day +15 to day +60 post-transplant
proportion of participants with deep vein thrombosis	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 post-transplant

Trial Locations

Locations (1)

Peking University Cancer Hospital & Institute; 🇨🇳 Beijing, Beijing, China