Allogeneic Hematopoietic Stem Cell Transplantation, Delayed Platelet Engraftment, Myeloablative
Conditions
Keywords
Allogeneic Hematopoietic Stem Cell Transplantation, Platelet Engraftment, TPO
Brief summary
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.
Interventions
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.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Guangdong Provincial People's 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
Nanfang Hospital, Southern Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Response Rate to TPO | 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
| Measure | Time frame | Description |
|---|---|---|
| Transplantation Related Mortality (TRM) | 1 year | Transplantation related mortality (TRM) in two arms after Allo-HSCT. |
Countries
China
Contacts
Primary ContactHongsheng Zhou, PhD MD
Outcome results
None listed