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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01379391
First Posted: June 23, 2011
Last Update Posted: October 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Guangdong General Hospital
Guangdong No.2 Provincial People's Hospital
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou Overseas Chinese Hospital,Guangdong
Zhongshan People's Hospital, Guangdong, China
Southern Medical University, China
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
  Purpose

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.


Condition Intervention Phase
Allogeneic Hematopoietic Stem Cell Transplantation Myeloablative Delayed Platelet Engraftment Drug: Recombinant Human Thrombopoietin (rHTPO) Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • Transplantation Related Mortality (TRM) [ Time Frame: 1 year ]
    Transplantation related mortality (TRM) in two arms after Allo-HSCT.


Estimated Enrollment: 80
Study Start Date: June 2010
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379391


Contacts
Contact: Hongsheng Zhou, PhD MD 86-20-62787883 hanson2008@gmail.com

Locations
China, Guangdong
Guangzhou General Hospital of Guangzhou Military Command Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Yang Xiao, MD       jdxiao111@163.com   
Principal Investigator: Yang Xiao, MD         
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510030
Contact: Suijin Wu, MD       songwu55555@163.com   
Principal Investigator: Suijin Wu, MD         
First Affiliated Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Duorong Xu, MD       xudr@hotmail.com   
Principal Investigator: Duorong Xu, MD         
Zhujiang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510282
Contact: Yuhua Li, MD PhD       li_yuhua@yahoo.com   
Principal Investigator: Yuhua Li, MD PhD         
Guangdong No.2 Provincial People's Hospital Recruiting
Guangzhou, Guangdong, China, 510317
Contact: Qing Zhang, MD       zhqing@vip.163.com   
Principal Investigator: Qing Zhang, MD         
Nanfang Hospital Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Hongsheng Zhou, MD PhD    86-20-62787883    hanson2008@gmail.com   
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 Overseas Chinese Hospital,Guangdong Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Kanger Zhu, MD       tzhuker@jnu.edu.cn   
Principal Investigator: Kanger Zhu, MD         
Third Affiliated Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Dongjun Lin, MD       lindongjun0168@163.com   
Principal Investigator: Dongjun Lin, MD         
Zhongshan People Hospital,Guangdong Recruiting
Zhongshan, Guangdong, China, 528403
Contact: Xiaojun Xu, MD       doctorxu@163.com   
Principal Investigator: Xiaojun Xu, MD         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
First Affiliated Hospital, Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Guangdong General Hospital
Guangdong No.2 Provincial People's Hospital
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou Overseas Chinese Hospital,Guangdong
Zhongshan People's Hospital, Guangdong, China
Southern Medical University, China
Investigators
Principal Investigator: Jing Sun, MD Department of Hematology, Nanfang Hospital
  More Information

Additional Information:
Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01379391     History of Changes
Other Study ID Numbers: TPO-HSCT-2011
First Submitted: June 20, 2011
First Posted: June 23, 2011
Last Update Posted: October 9, 2015
Last Verified: September 2015

Keywords provided by Nanfang Hospital of Southern Medical University:
Allogeneic Hematopoietic Stem Cell Transplantation
Platelet Engraftment
TPO