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

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ClinicalTrials.gov Identifier: NCT03010579
Recruitment Status : Unknown
Verified January 2017 by Jun Zhu, Peking University.
Recruitment status was:  Recruiting
First Posted : January 5, 2017
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Jun Zhu, Peking University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Lymphoma

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 Name: 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 Name: ferrous succinate




Primary Outcome Measures :
  1. complete hemoglobin response rate [ Time Frame: 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 :
  1. proportion of participants with red blood cell transfusions [ Time Frame: 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

  2. proportion of participants with deep vein thrombosis [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010579


Locations
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China, Beijing
Peking University Cancer Hospital & Institute Recruiting
Beijing, Beijing, China, 100142
Contact: Wei Ping Liu       dreaming2217@126.com   
Contact: Xiao Pei Wang       cadillac570@163.com   
Sponsors and Collaborators
Peking University

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Responsible Party: Jun Zhu, Chairman of Lymphoma Department, Peking University
ClinicalTrials.gov Identifier: NCT03010579     History of Changes
Other Study ID Numbers: PKU-2016KT64
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jun Zhu, Peking University:
Anemia
Lymphoma
Hematopoietic stem cell transplantation
Erythropoietin

Additional relevant MeSH terms:
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Lymphoma
Anemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Vitamins
Folic Acid
Vitamin B 12
Hydroxocobalamin
Epoetin Alfa
Ferrous succinate
Hematinics
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs