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

Phase 1

• Conditions: Hematopoietic Stem Cell Transplantation; Thrombocytopoietin; Hematopoietic Stem Cell Mobilization
• Interventions: Drug: Recombinant Human Thrombopoietin

• Registration Number: NCT03014102
• Lead Sponsor: Hongnan Mo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-01-06
• Study First Posted: 2017-01-09
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-05
• Last Update Posted: 2019-12-06
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TPOqod	Recombinant Human Thrombopoietin	Recombinant Human Thrombopoietin 300U/kg/d ih qua altera die, day-3/-1/+2 before mobilization
TPOqd	Recombinant Human Thrombopoietin	Recombinant Human Thrombopoietin 300U/kg/d ih quaque die, day-3/-2/-1 before mobilization

Primary Outcome Measures

Name	Time	Method
the average number of cluster of differentiation 34 positive cells/kg	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.

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China