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

Primary Purpose

Anemia, Lymphoma, Hematopoietic Stem Cell Transplantation

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
erythropoietin
iron supplementation
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, Lymphoma, Hematopoietic stem cell transplantation, Erythropoietin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Peking University Cancer Hospital & InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

erythropoietin group

iron supplementation

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

proportion of participants with red blood cell transfusions
proportion of participants with red blood cell transfusions from day +15 to day +60 post-transplant
proportion of participants with deep vein thrombosis
proportion of participants with deep vein thrombosis from day +15 to day +60 post-transplant

Full Information

First Posted
December 29, 2016
Last Updated
January 3, 2017
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT03010579
Brief Title
Erythropoietin in the Treatment of Anemia After Autologous Hematopoietic Stem Cell Transplantation
Official Title
Efficacy and Safety of Erythropoietin in the Treatment of Anemia in Patients With Lymphoma After Autologous Hematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Lymphoma, Hematopoietic Stem Cell Transplantation
Keywords
Anemia, Lymphoma, Hematopoietic stem cell transplantation, Erythropoietin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
erythropoietin group
Arm Type
Experimental
Arm 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.
Arm Title
iron supplementation
Arm Type
Active Comparator
Arm Description
If necessary，oral ferrous succinate, vitamins B12 and folic acid will be administered.
Intervention Type
Drug
Intervention Name(s)
erythropoietin
Other Intervention Name(s)
Erythropoiesis-Stimulating Agent
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
iron supplementation
Other Intervention Name(s)
ferrous succinate
Intervention Description
If necessary, oral ferrous succinate, vitamins B12 and folic acid will be administered.
Primary Outcome Measure Information:
Title
complete hemoglobin response rate
Description
proportion of complete correctors (reaching hemoglobin 120 g/L in male patients, 110 g/L in female patients) before day +60 post-transplant
Time Frame
from day +15 to day +60 after autologous hematopoietic stem cell transplantation
Secondary Outcome Measure Information:
Title
proportion of participants with red blood cell transfusions
Description
proportion of participants with red blood cell transfusions from day +15 to day +60 post-transplant
Time Frame
from day +15 to day +60 after autologous hematopoietic stem cell transplantation
Title
proportion of participants with deep vein thrombosis
Description
proportion of participants with deep vein thrombosis from day +15 to day +60 post-transplant
Time Frame
from day +15 to day +60 after autologous hematopoietic stem cell transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Peking University Cancer Hospital & Institute
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Ping Liu
Email
dreaming2217@126.com
First Name & Middle Initial & Last Name & Degree
Xiao Pei Wang
Email
cadillac570@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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