Efficacy and Safety of rHuTPO on Platelet Engraftment After Allo-HSCT (TPO)
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|ClinicalTrials.gov Identifier: NCT01379391|
Recruitment Status : Unknown
Verified September 2015 by Nanfang Hospital of Southern Medical University.
Recruitment status was: Recruiting
First Posted : June 23, 2011
Last Update Posted : October 9, 2015
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 or disease||Intervention/treatment||Phase|
|Allogeneic Hematopoietic Stem Cell Transplantation Myeloablative Delayed Platelet Engraftment||Drug: Recombinant Human Thrombopoietin (rHTPO)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||September 2015|
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
- 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.
- Transplantation Related Mortality (TRM) [ Time Frame: 1 year ]Transplantation related mortality (TRM) in two arms after Allo-HSCT.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379391
|Contact: Hongsheng Zhou, PhD MDfirstname.lastname@example.org|
|Guangzhou General Hospital of Guangzhou Military Command||Recruiting|
|Guangzhou, Guangdong, China, 510010|
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|Contact: Hongsheng Zhou, MD PhD 86-20-62787883 firstname.lastname@example.org|
|Sub-Investigator: Hongsheng Zhou, MD PhD|
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|Zhongshan, Guangdong, China, 528403|
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|Principal Investigator: Xiaojun Xu, MD|
|Principal Investigator:||Jing Sun, MD||Department of Hematology, Nanfang Hospital|