Efficacy and Safety of rHuTPO on Platelet Engraftment After Allo-HSCT (TPO)

October 7, 2015 updated by: Nanfang Hospital of Southern Medical University

A Phase IV, Open-label, Prospective, Multicenter Study of the Efficacy and Safety of Recombinant Human Thrombopoietin Injection (rHuTPO, TPIAO)on Platelet Engraftment in Allogeneic Hematopoietic Stem Cell Transplantation in China

Factors influencing platelet engraftment after allogeneic hematopoietic stem cell transplantation (Allo-HSCT) includes previous chemotherapy courses, conditioning regimen, HLA compatibility, source of stem cell, CD34+ cell count, infection of virus/bacteria/fungal, graft-versus-host disease (GVHD), etc. Large-scaled clinical trials have demonstrated that platelet count below 20G/L on 14 days after transplantation is an predictive factor for delayed platelet engraftment, which lead to increased platelet infusion requirement and high risk of bleeding. Multivariable survival analysis indicated that delayed platelet engraftment in Allo-HSCT is independent predictive factor for transplantation related mortality (TRM). But effective treatment approaches for delayed platelet recovery after Allo-HSCT are still lacking now.

Recombinant human thrombopoietin (rHuTPO) is a fully modified recombinant human thrombopoietin accurately expressed in mammalian cells. The rHuTPO agent manufactured by the 3Bio Pharmaceutical Limited Liability Company (LLC) in Shenyang is approved by the State Food and Drug Administration (SFDA) of China in 2005 and is the first rHuTPO agent available globally. RHuTPO was approved for for immune thrombocytopenia and chemotherapy-related thrombocytopenia in China. Animal experiments showed that TPO-mobilizing stem cell could promote platelet engraftment in Allo-HSCT in mice. As for efficacy and safety of TPO on platelet engraftment after Allo-HSCT, it's marginally addressed in clinical trials.

Based on preliminary research results, investigator designed a phase IV, open-label, prospective, multicenter Study of the efficacy and safety of recombinant human thrombopoietin injection (rHuTPO, TPIAO)on platelet engraftment in Allo-HSCT in China.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510010
        • Recruiting
        • Guangzhou General Hospital of Guangzhou Military Command
        • Contact:
        • Principal Investigator:
          • Yang Xiao, MD
      • Guangzhou, Guangdong, China, 510030
        • Recruiting
        • Guangdong General Hospital
        • Contact:
        • Principal Investigator:
          • Suijin Wu, MD
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • First Affiliated Hospital, Sun Yat-Sen University
        • Contact:
        • Principal Investigator:
          • Duorong Xu, MD
      • Guangzhou, Guangdong, China, 510282
        • Recruiting
        • Zhujiang Hospital of Southern Medical University
        • Contact:
        • Principal Investigator:
          • Yuhua Li, MD PhD
      • Guangzhou, Guangdong, China, 510317
        • Recruiting
        • Guangdong No.2 Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Qing Zhang, MD
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital
        • Contact:
        • Sub-Investigator:
          • Hongsheng Zhou, MD PhD
        • Sub-Investigator:
          • Qifa Liu, MD
        • Sub-Investigator:
          • Guopan Yu, MD
        • Sub-Investigator:
          • Xian Zhang, MD
        • Sub-Investigator:
          • Feng Huang, MD
        • Sub-Investigator:
          • Mo Yang, PhD MD
        • Sub-Investigator:
          • Fanyi Meng, MD
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Guangzhou Overseas Chinese Hospital,Guangdong
        • Contact:
        • Principal Investigator:
          • Kanger Zhu, MD
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Third Affiliated Hospital, Sun Yat-Sen University
        • Contact:
        • Principal Investigator:
          • Dongjun Lin, MD
      • Zhongshan, Guangdong, China, 528403
        • Recruiting
        • Zhongshan People Hospital,Guangdong
        • Contact:
        • Principal Investigator:
          • Xiaojun Xu, MD

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ages: 18 years to 65 years.
  2. Patients received myeloablative allogeneic hematopoietic stem cell transplantation from related or non-related, HLA compatible or incompatible donors. History controls or concurrent controls are used.
  3. The platelet count is lower than 20G/L on +14d post-transplant .
  4. The informed consent form has been signed.
  5. The following exclusion criteria are excluded.

Exclusion Criteria:

  1. Patients received non-myeloablative hematopoietic stem cell transplantation.
  2. Patients with severe cardio-cerebral diseases with over grade III A YHA cardiac function or with past history of coronary heart disease, cerebral thrombosis, cerebral arteriosclerosis, etc.
  3. Patients with severe hepatic or renal dysfunction with more than 5 times the upper limit of normal range (ULN) of serum ALT or AST levels, or with more than 5 times the upper limit of normal range (ULN) of serum TBIL level or less than 40% of normal prothrombin time activity (PTA); or with more than 3 times the ULN of serum Cr.
  4. Patients with history of deep vein thrombosis within 8 weeks of enrollment.
  5. Patients with hepatic obstructive venous disease without recovery within 2 weeks of enrollment.
  6. Patients with thrombotic microangiopathy without recovery within 2 weeks of enrollment.
  7. Patients with capillary leaking syndrome without recovery within 2 weeks of enrollment.
  8. Patients with other conditions considered unsuitable for the study.
  9. Patients with hypercoagulopathy condition with two or more of these criteria: INR lower than 0.82, APTT lower than the lower limit of normal values (23 seconds) or PT lower than the lower limit of normal values (10 seconds).

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TPO
Patients received myeloablative Allo-HSCT with platelet lower than 20G/L on +14d post-transplantation. Patient enrolled in TPO arm will recieved Recombinant Human Thrombopoietin (rHTPO) treatment fro 14 days.
Drug: Recombinant Human Thrombopoietin (rHTPO)

Patients received allogeneic myeloablative hematopoietic stem cell transplantation with platelet count lower than 20G/L on +14 days after Allo-HSCT, met the above enrollment criteria and signed the informed consent forms are eligible subjects.

Administration method of rHuTPO: 300U/kg/d by percutaneous injection; Timing: d14 to d28 after Allo-HSCT.
No Intervention: TPO-Free Arm
No TPO intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Response Rate to TPO
Time Frame: 4 weeks

Response Rate is selected as primary outcome for measuring efficacy of TPO for patients with delayed platelet engraftment after Allo-HSCT.

Markedly response: Platelet count of more than 50G/L in complete blood count on +28d post-transplantation after finishing 14-day course of TPO intervention, or PLT≥100G/L within the 14-day course.

Response: PLT 20-50G/L on +28 day after completing the 14-day course. No response: PLT <20G/L on +28 day after completing the 14-day course.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transplantation Related Mortality (TRM)
Time Frame: 1 year
Transplantation related mortality (TRM) in two arms after Allo-HSCT.
1 year

Collaborators and Investigators

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

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University
Guangdong Provincial People's Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou General Hospital of Guangzhou Military Command
Southern Medical University, China
Guangdong No.2 Provincial People's Hospital
Guangzhou Overseas Chinese Hospital,Guangdong
Zhongshan People's Hospital, Guangdong, China

Investigators

  • Principal Investigator: Jing Sun, MD, Department of Hematology, Nanfang Hospital

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.

Helpful Links

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, 2010

Primary Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

June 20, 2011

First Submitted That Met QC Criteria

June 21, 2011

First Posted (Estimate)

June 23, 2011

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TPO-HSCT-2011

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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