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Recombinant Human Thrombopoietin for Mobilization of Peripheral Blood Progenitor Cells for Autologous Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03014102
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Hongnan Mo, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary:
The purpose of this study is to determine whether recombinant human thrombopoietin are effective in peripheral blood progenitor cells mobilization for autologous transplantation.

Condition or disease Intervention/treatment Phase
Thrombocytopoietin Hematopoietic Stem Cell Mobilization Hematopoietic Stem Cell Transplantation Drug: Recombinant Human Thrombopoietin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : June 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: TPOqd
Recombinant Human Thrombopoietin 300U/kg/d ih quaque die, day-3/-2/-1 before mobilization
Drug: Recombinant Human Thrombopoietin
Recombinant human Thrombopoietin is a full length glycosylated molecule identical to endogenous Thrombopoietin.

Active Comparator: TPOqod
Recombinant Human Thrombopoietin 300U/kg/d ih qua altera die, day-3/-1/+2 before mobilization
Drug: Recombinant Human Thrombopoietin
Recombinant human Thrombopoietin is a full length glycosylated molecule identical to endogenous Thrombopoietin.




Primary Outcome Measures :
  1. the average number of cluster of differentiation 34 positive cells/kg [ Time Frame: up to 24 months ]
    To evaluate the effect of combining various treatment schedules of recombinant human thrombopoietin with granulocyte colony stimulating factor on the mobilization of peripheral blood progenitor cells.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a histologically confirmed diagnosis of Hodgkin's disease, non-Hodgkin's lymphoma, or selected high-risk solid tumors that are planned to receive autologous peripheral blood progenitor cell transplantation
  • Eastern Cooperative Oncology Group performance status of 0 - 2.

Exclusion Criteria:

  • abnormal liver function (aminotransferase or bilirubin levels 2 times upper limit of normal), leukopenia (white blood cell count 3000/L), or a history of platelet or other disorders associated with a bleeding diathesis
  • a history of thromboembolic disease, coronary heart disease,stroke, arrhythmias, central nervous system metastases,or other organ system diseases or abnormalities that might predispose individuals to treatment-related complications

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): NCT03014102


Contacts
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Contact: Hongnan Mo, MD 8610-87787451 mhnzlyynk@outlook.com

Locations
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China, Beijing
Cancer Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Hongnan Mo, MD    8610-87788103    mhnzlyynk@outlook.com   
Sponsors and Collaborators
Hongnan Mo
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Responsible Party: Hongnan Mo, Attending Physician, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03014102    
Other Study ID Numbers: LC2016B03
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019