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

NCT ID: NCT03014102

Last Updated: 2019-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-09-30

Brief Summary

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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

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Conditions

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Thrombocytopoietin Hematopoietic Stem Cell Mobilization Hematopoietic Stem Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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TPOqd

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

Group Type EXPERIMENTAL

Recombinant Human Thrombopoietin

Intervention Type DRUG

Recombinant human Thrombopoietin is a full length glycosylated molecule identical to endogenous Thrombopoietin.

TPOqod

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

Group Type ACTIVE_COMPARATOR

Recombinant Human Thrombopoietin

Intervention Type DRUG

Recombinant human Thrombopoietin is a full length glycosylated molecule identical to endogenous Thrombopoietin.

Interventions

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Recombinant Human Thrombopoietin

Recombinant human Thrombopoietin is a full length glycosylated molecule identical to endogenous Thrombopoietin.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hongnan Mo

OTHER

Sponsor Role lead

Responsible Party

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Hongnan Mo

Attending Physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongnan Mo, MD

Role: CONTACT

Phone: 8610-87787451

Email: [email protected]

Facility Contacts

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Hongnan Mo, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 34505019 (View on PubMed)

Other Identifiers

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LC2016B03

Identifier Type: -

Identifier Source: org_study_id