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

Peking University

Status and phase: Unknown; Phase 4

Conditions: Anemia; Hematopoietic Stem Cell Transplantation; Lymphoma

Treatments: Drug: erythropoietin; Drug: iron supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT03010579

PKU-2016KT64

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

erythropoietin group

Experimental group

Description:

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.

Treatment:

Drug: erythropoietin

iron supplementation

Active Comparator group

Description:

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

Treatment:

Drug: iron supplementation