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

Sponsor

Peking University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03010579

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia Lymphoma Hematopoietic Stem Cell Transplantation	Drug: erythropoietin Drug: iron supplementation	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: erythropoietin 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. Other Names: Erythropoiesis-Stimulating Agent
Active Comparator: iron supplementation If necessary，oral ferrous succinate, vitamins B12 and folic acid will be administered.	Drug: iron supplementation If necessary, oral ferrous succinate, vitamins B12 and folic acid will be administered. Other Names: ferrous succinate

Arm

Intervention/Treatment

Experimental: 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.

Drug: erythropoietin

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.

Other Names:

Erythropoiesis-Stimulating Agent

Active Comparator: iron supplementation

If necessary，oral ferrous succinate, vitamins B12 and folic acid will be administered.

Drug: iron supplementation

If necessary, oral ferrous succinate, vitamins B12 and folic acid will be administered.

Other Names:

ferrous succinate

Outcome Measures

Primary Outcome Measures

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

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