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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03010579
• Other study ID #: PKU-2016KT64
• Status: Recruiting
• Phase: Phase 4
• First received: December 29, 2016
• Last updated: January 3, 2017
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: January 2017
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Hematopoietic Stem Cell Transplantation
• Lymphoma

Intervention

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

Locations

Country	Name	City	State
China	Peking University Cancer Hospital & Institute	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete hemoglobin response rate	proportion of complete correctors (reaching hemoglobin 120 g/L in male patients, 110 g/L in female patients) before day +60 post-transplant	from day +15 to day +60 after autologous hematopoietic stem cell transplantation	No
Secondary	proportion of participants with red blood cell transfusions	proportion of participants with red blood cell transfusions from day +15 to day +60 post-transplant	from day +15 to day +60 after autologous hematopoietic stem cell transplantation	No
Secondary	proportion of participants with deep vein thrombosis	proportion of participants with deep vein thrombosis from day +15 to day +60 post-transplant	from day +15 to day +60 after autologous hematopoietic stem cell transplantation	No