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

Hematopoietic Stem Cell Transplantation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03014102
• Other study ID #: LC2016B03
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 2016
• Est. completion date: September 2020

Study information

• Verified date: December 2019
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Hongnan Mo, MD
• Phone: 8610-87787451
• Email: mhnzlyynk[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Mobilization
• Hematopoietic Stem Cell Transplantation
• Thrombocytopoietin

Intervention

Drug:
• Recombinant Human Thrombopoietin
Recombinant human Thrombopoietin is a full length glycosylated molecule identical to endogenous Thrombopoietin.

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Hongnan Mo

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the average number of cluster of differentiation 34 positive cells/kg	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.	up to 24 months