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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03010579

Enrollment

Registered

2017-01-05

Start date

2016-10-31

Completion date

2018-12-31

Last updated

2017-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Hematopoietic Stem Cell Transplantation, Lymphoma

Keywords

Anemia, Lymphoma, Hematopoietic stem cell transplantation, Erythropoietin

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.

Interventions

DRUGerythropoietin

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.

DRUGiron supplementation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026