- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03010579
Erythropoietin in the Treatment of Anemia After Autologous Hematopoietic Stem Cell Transplantation
January 3, 2017 updated by: Jun Zhu, Peking University
Efficacy and Safety of Erythropoietin in the Treatment of Anemia in Patients With Lymphoma After Autologous Hematopoietic Stem Cell Transplantation
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.
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Recruiting
- Peking University Cancer Hospital & Institute
-
Contact:
- Wei Ping Liu
- Email: dreaming2217@126.com
-
Contact:
- Xiao Pei Wang
- Email: cadillac570@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
Active Comparator: iron supplementation
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
from day +15 to day +60 after autologous hematopoietic stem cell transplantation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
from day +15 to day +60 after autologous hematopoietic stem cell transplantation
|
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
|
from day +15 to day +60 after autologous hematopoietic stem cell transplantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
December 29, 2016
First Submitted That Met QC Criteria
January 3, 2017
First Posted (Estimate)
January 5, 2017
Study Record Updates
Last Update Posted (Estimate)
January 5, 2017
Last Update Submitted That Met QC Criteria
January 3, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PKU-2016KT64
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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