Recombinant Human Thrombopoietin for Mobilization of Peripheral Blood Progenitor Cells for Autologous Transplantation
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2016
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 5, 2017
CompletedFirst Posted
Study publicly available on registry
January 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedDecember 6, 2019
December 1, 2019
4.3 years
January 5, 2017
December 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
TPOqd
EXPERIMENTALRecombinant Human Thrombopoietin 300U/kg/d ih quaque die, day-3/-2/-1 before mobilization
TPOqod
ACTIVE COMPARATORRecombinant Human Thrombopoietin 300U/kg/d ih qua altera die, day-3/-1/+2 before mobilization
Interventions
Recombinant human Thrombopoietin is a full length glycosylated molecule identical to endogenous Thrombopoietin.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hongnan Molead
Study Sites (1)
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Related Publications (1)
Mo H, Liu P, Qin Y, He X, Han X, Yao J, Su W, Zhang S, Tang L, Zhao F, Gui L, Yang S, Yang J, Zhou S, Zhang Z, Shi Y. Recombinant human thrombopoietin prior to mobilization chemotherapy facilitates platelet recovery in autologous transplantation in patients with lymphoma: Results of a prospective randomized study. Chronic Dis Transl Med. 2021 Jun 24;7(3):190-198. doi: 10.1016/j.cdtm.2021.05.003. eCollection 2021 Sep.
PMID: 34505019DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
January 5, 2017
First Posted
January 9, 2017
Study Start
June 1, 2016
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
December 6, 2019
Record last verified: 2019-12