Allogeneic Hematopoietic Stem Cell TransplantationPhase 4TPONCT01379391
Efficacy and Safety of rHuTPO on Platelet Engraftment After Allo-HSCT
A Phase 4 study testing Recombinant Human Thrombopoietin (rHTPO) in people with Allogeneic Hematopoietic Stem Cell Transplantation and Myeloablative, run by Nanfang Hospital, Southern Medical University at 9 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation, Myeloablative, Delayed Platelet Engraftment
- What is being tested?
- Recombinant Human Thrombopoietin (rHTPO)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 9 sitesChina
- Study dates
- Jun 2010to Sep 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages: 18 years to 65 years.
- 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.
- The platelet count is lower than 20G/L on +14d post-transplant .
- The informed consent form has been signed.
- The following exclusion criteria are excluded.
Who cannot join
- Patients received non-myeloablative hematopoietic stem cell transplantation.
- 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.
- 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.
- Patients with history of deep vein thrombosis within 8 weeks of enrollment.
- Patients with hepatic obstructive venous disease without recovery within 2 weeks of enrollment.
- Patients with thrombotic microangiopathy without recovery within 2 weeks of enrollment.
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- Patients with capillary leaking syndrome without recovery within 2 weeks of enrollment.
- Patients with other conditions considered unsuitable for the study.
- 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).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, 510010
Yang Xiao, MD, jdxiao111@163.com
Yang Xiao, MD
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510030
Suijin Wu, MD, songwu55555@163.com
Suijin Wu, MD
- Recruiting
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Duorong Xu, MD, xudr@hotmail.com
Duorong Xu, MD
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510282
Yuhua Li, MD PhD, li_yuhua@yahoo.com
Yuhua Li, MD PhD
- Recruiting
Guangdong No.2 Provincial People's Hospital
Guangzhou, Guangdong, 510317
Qing Zhang, MD, zhqing@vip.163.com
Qing Zhang, MD
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong, 510515
Hongsheng Zhou, MD PhD, 86-20-62787883, hanson2008@gmail.com
Hongsheng Zhou, MD PhD
- Recruiting
Guangzhou Overseas Chinese Hospital,Guangdong
Guangzhou, Guangdong, 510630
Kanger Zhu, MD, tzhuker@jnu.edu.cn
Kanger Zhu, MD
- Recruiting
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510630
Dongjun Lin, MD, lindongjun0168@163.com
Dongjun Lin, MD
- Recruiting
Zhongshan People Hospital,Guangdong
Zhongshan, Guangdong, 528403
Xiaojun Xu, MD, doctorxu@163.com
Xiaojun Xu, MD
About this study
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
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.
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation, Myeloablative, Delayed Platelet Engraftment
- Being tested
- Recombinant Human Thrombopoietin (rHTPO)
- Keywords
- Allogeneic Hematopoietic Stem Cell Transplantation, Platelet Engraftment, TPO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Recombinant Human Thrombopoietin (rHTPO) |
| TPO-Free Arm | No intervention | No TPO intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
Transplantation Related Mortality (TRM)
Transplantation related mortality (TRM) in two arms after Allo-HSCT.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startJun 2010
- Primary completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Jing Sun, MD, Principal investigator, Department of Hematology, Nanfang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379391
- Sponsor's protocol ID
- TPO-HSCT-2011
- Acronym
- TPO
- Status last verified
- Sep 2015
- First submitted
- 20 Jun 2011
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01379391
- Acronym / sponsor ID
- TPO / TPO-HSCT-2011
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation, Myeloablative, Delayed Platelet Engraftment
- Keywords
- Allogeneic Hematopoietic Stem Cell Transplantation, Platelet Engraftment, TPO
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- 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
- Study start
- Jun 2010
- Primary completion
- Sep 2015 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPO | Active comparator | Drug: Recombinant Human Thrombopoietin (rHTPO)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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages: 18 years to 65 years.
- 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.
- The platelet count is lower than 20G/L on +14d post-transplant .
- The informed consent form has been signed.
- The following exclusion criteria are excluded.
Key exclusion criteria (9 listed)
- Patients received non-myeloablative hematopoietic stem cell transplantation.
- 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.
- 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.
- Patients with history of deep vein thrombosis within 8 weeks of enrollment.
- Patients with hepatic obstructive venous disease without recovery within 2 weeks of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | TPO |
Primary outcome
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.
1 secondary outcome
Transplantation Related Mortality (TRM)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
- Website of Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Sun, MD principal investigator
Department of Hematology, Nanfang Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Recombinant Human Thrombopoietin (rHTPO) in people with Allogeneic Hematopoietic Stem Cell Transplantation and Myeloablative, run by Nanfang Hospital, Southern Medical University at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongsheng Zhou, PhD MD (86-20-62787883, hanson2008@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Response Rate to TPO (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2015.