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

NCT03010579 — Phase 4, Unknown, 70 participants, Peking University

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

Registry	NCT03010579
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	70 (Estimated)
Sponsor	Peking University (Other)
Conditions	Anemia, Lymphoma, Hematopoietic Stem Cell Transplantation
Interventions	erythropoietin, iron supplementation (Drug)
Dates	start 2016-10-01, primary completion 2017-12-01 (estimated), completion 2018-12-01 (estimated), first posted 2017-01-05, last updated 2017-01-05
Locations	1 site in China

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
erythropoietin group	Experimental	Drug: 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.
iron supplementation	Active comparator	Drug: iron supplementation	If necessary，oral ferrous succinate, vitamins B12 and folic acid will be administered.

erythropoietin (Drug), also known as Erythropoiesis-Stimulating Agent: 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.
iron supplementation (Drug), also known as ferrous succinate: If necessary, oral ferrous succinate, vitamins B12 and folic acid will be administered.

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Peking University Cancer Hospital & Institute	Beijing, Beijing Municipality	China	Recruiting

My Notes

Public

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