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

• Sponsor: Hongnan Mo (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03014102
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 51
• Patients Per Site Per Month: 1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Study Start Date: Jun 1, 2016
• Anticipated Primary Completion Date: Sep 1, 2020
• Anticipated Study Completion Date: Sep 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing	China	100021

Sponsors and Collaborators

• Hongnan Mo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Jan 9, 2017
• Last Update Posted: Dec 6, 2019
• Last Verified: Dec 1, 2019

Study Results

No Results Posted as of Dec 6, 2019