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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPO | Active Comparator | 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. |
|
| TPO-Free Arm | No Intervention | No TPO intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Thrombopoietin (rHTPO) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Response Rate to TPO | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Transplantation Related Mortality (TRM) | Transplantation related mortality (TRM) in two arms after Allo-HSCT. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongsheng Zhou, PhD MD | Contact | 86-20-62787883 | hanson2008@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Sun, MD | Department of Hematology, Nanfang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou General Hospital of Guangzhou Military Command | Recruiting | Guangzhou | Guangdong | 510010 | China |
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| Label | URL |
|---|---|
| Website of Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China. | View source |
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| Guangdong No.2 Provincial People's Hospital |
| OTHER |
| Guangzhou General Hospital of Guangzhou Military Command | OTHER |
| Guangzhou Overseas Chinese Hospital,Guangdong | UNKNOWN |
| Zhongshan People's Hospital, Guangdong, China | OTHER |
| Southern Medical University, China | OTHER |
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| Guangdong General Hospital | Recruiting | Guangzhou | Guangdong | 510030 | China |
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| First Affiliated Hospital, Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| Zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510282 | China |
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| Guangdong No.2 Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510317 | China |
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| Nanfang Hospital | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| Guangzhou Overseas Chinese Hospital,Guangdong | Recruiting | Guangzhou | Guangdong | 510630 | China |
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| Third Affiliated Hospital, Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510630 | China |
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| Zhongshan People Hospital,Guangdong | Recruiting | Zhongshan | Guangdong | 528403 | China |
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| ID | Term |
|---|---|
| D013926 | Thrombopoietin |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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