Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01379391
Other study ID # TPO-HSCT-2011
Secondary ID
Status Recruiting
Phase Phase 4
First received June 20, 2011
Last updated October 7, 2015
Start date June 2010

Study information

Verified date September 2015
Source Nanfang Hospital of Southern Medical University
Contact Hongsheng Zhou, PhD MD
Phone 86-20-62787883
Email hanson2008@gmail.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

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

Sponsors (9)

Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University First 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, Southern Medical University, China, Third Affiliated Hospital, Sun Yat-Sen University, Zhongshan People's Hospital, Guangdong, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Transplantation Related Mortality (TRM) Transplantation related mortality (TRM) in two arms after Allo-HSCT. 1 year Yes
See also
  Status Clinical Trial Phase
Recruiting NCT03294824 - Non Randomized Comparative Study With Control
Recruiting NCT04098653 - Decitabine + BUCY vs BUCY Conditioning Regimen for Myeloid Tumors Undergoing Allo-HSCT Phase 2/Phase 3
Recruiting NCT03256071 - Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT Phase 2/Phase 3
Terminated NCT02653196 - A Multi-Institutional Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Malignant Neuro-Epithelial and Other Solid Tumors Early Phase 1
Terminated NCT00429039 - A Study to Accelerate Immune System Recovery Following Stem Cell Transplantation Phase 2
Recruiting NCT06028828 - Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation Phase 2
Recruiting NCT05084027 - Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT Phase 2
Recruiting NCT04123392 - Decitabine + BUCY vs BUCY Conditioning Regimen for TP53+ Myeloid Tumors Undergoing Allo-HSCT Phase 2/Phase 3
Recruiting NCT05596981 - The Gut Microbiome in FLT3-ITD+ AML Undergoing Allo-HSCT With Or Without Sorafenib Maintenance After Allo-HSCT
Recruiting NCT05596968 - The Gut Microbiome and Sorafenib Maintenance Therapy in FLT3-ITD Positive AML After Allo-HSCT
Recruiting NCT05601895 - The Gut Microbiome in FLT3- AL Undergoing Allo-HSCT With Or Without Sorafenib Maintenance
Recruiting NCT03357172 - Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation N/A
Active, not recruiting NCT04995653 - A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT Phase 1
Completed NCT02250300 - MLN9708 for the Prophylaxis of Chronic Graft-versus-host Disease in Patient Undergoing Allogeneic Transplantation Phase 1/Phase 2
Recruiting NCT04372524 - Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
Recruiting NCT03593161 - Humor Therapy and Distress After Allogeneic Stem Cell Transplantation N/A
Recruiting NCT05379569 - Comparative Study of BFC and BuCy Conditioning Regimen for Allo-PBSCT in Acute B-cell ALL Phase 4
Not yet recruiting NCT03902041 - The Prospective Randomized Controlled Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic HSCT
Completed NCT02270346 - Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients N/A
Recruiting NCT03297528 - Chemotherapy and DLI for Prevention of Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant Phase 2