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

Hongnan Mo

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Hematopoietic Stem Cell Mobilization; Hematopoietic Stem Cell Transplantation; Thrombocytopoietin

Treatments: Drug: Recombinant Human Thrombopoietin

Study type: Interventional

Funder types: Other

Identifiers

NCT03014102

LC2016B03

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

TPOqd

Experimental group

Description:

Recombinant Human Thrombopoietin 300U/kg/d ih quaque die, day-3/-2/-1 before mobilization

Treatment:

Drug: Recombinant Human Thrombopoietin

TPOqod

Active Comparator group

Description:

Recombinant Human Thrombopoietin 300U/kg/d ih qua altera die, day-3/-1/+2 before mobilization

Treatment:

Drug: Recombinant Human Thrombopoietin