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

December 5, 2019 updated by: Hongnan Mo
The purpose of this study is to determine whether recombinant human thrombopoietin are effective in peripheral blood progenitor cells mobilization for autologous transplantation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the average number of cluster of differentiation 34 positive cells/kg
Time Frame: 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.
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hongnan Mo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2020

Study Completion (ANTICIPATED)

September 1, 2020

Study Registration Dates

First Submitted

January 5, 2017

First Submitted That Met QC Criteria

January 6, 2017

First Posted (ESTIMATE)

January 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 6, 2019

Last Update Submitted That Met QC Criteria

December 5, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • LC2016B03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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