ThrombocytopeniaNCT07747246
Retrospective Study of Romiplostim for Platelet Engraftment After Allo-HSCT
An observational study of Thrombocytopenia, run by Tongji Hospital at 1 site in China.
Trial summary
This is a retrospective observational study evaluating the efficacy and safety of romiplostim for promoting platelet engraftment in patients who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) at Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thrombocytopenia
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 15 Jul 2026
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent allo-HSCT at Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology (Wuhan, China) from January 2025 to May 2026.
Who may be able to join
- Patients diagnosed with AA, AL, MDS, PMF, or other hematologic diseases according to internationally accepted diagnostic criteria
- Patients who underwent allo-HSCT during the study period
- Patients with complete clinical characteristics, transplantation records, and follow-up data
Who cannot join
- Primary graft failure;
- Death before hematopoietic engraftment
- Missing key clinical data;(4) Use of thrombopoietin receptor agonists other than romiplostim
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Retrospective Clinical Study on the Efficacy and Safety of Romiplostim for Promoting Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation
This is a retrospective observational study evaluating the efficacy and safety of romiplostim for promoting platelet engraftment in patients who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) at Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology between January 2025 to May 2026. Medical records were reviewed to collect data on platelet recovery time, transfusion requirements, and adverse events. The primary endpoint was time to platelet engraftment. Secondary endpoints included platelet recovery kinetics, transfusion requirements, transplant-related complications, and safety outcomes.No interventions were assigned as part of this study.
Read the detailed description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an important curative treatment for various hematological malignancies and non-malignant hematological disorders. However, delayed platelet engraftment remains a frequent complication after transplantation and is associated with prolonged thrombocytopenia, increased bleeding risk, higher transfusion requirements, and extended hospitalization.
Romiplostim, a thrombopoietin receptor agonist (TPO-RA), promotes megakaryocyte proliferation, differentiation, and platelet production through activation of the thrombopoietin receptor (c-Mpl). Although romiplostim has been widely used in immune thrombocytopenia and chemotherapy-induced thrombocytopenia, its efficacy and safety in promoting platelet engraftment after allo-HSCT remain unclear.
The investigators retrospectively analyzed patients who underwent allo-HSCT at Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology between January 2025 to May 2026. Patients were categorized into a romiplostim group and a control group according to whether romiplostim was administered after transplantation.
To minimize baseline imbalance and potential confounding factors, propensity score matching (PSM) was performed at a 1:1 ratio.
The primary endpoint was time to platelet engraftment. Secondary endpoints included platelet recovery kinetics, transfusion requirements, transplant-related complications, and safety outcomes.
Kaplan-Meier analysis with log-rank testing and Cox proportional hazards regression models were performed to evaluate factors associated with platelet engraftment.
Inclusion Criteria:
- Patients diagnosed with AA, AL, MDS, PMF, or other hematologic diseases according to internationally accepted diagnostic criteria
- Patients who underwent allo-HSCT during the study period
- Patients with complete clinical characteristics, transplantation records, and follow-up data
Exclusion Criteria:
- Primary graft failure;
- Death before hematopoietic engraftment
- Missing key clinical data;(4) Use of thrombopoietin receptor agonists other than romiplostim
- Conditions
- Thrombocytopenia
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Romiplostim Group | Patients who received romiplostim after allogeneic hematopoietic stem cell transplantation for platelet engraftment. | |
| Control Group | Patients who did not receive romiplostim after allogeneic hematopoietic stem cell transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Platelet Recovery to ≥50×10⁹/L
Time from allogeneic hematopoietic stem cell transplantation (Day 0) to the first date of achieving platelet count ≥50×10⁹/L without transfusion support in the preceding 7 days.
Measured: up to Day 100
Secondary outcomes (2)
Time to Platelet Engraftment
Time from transplantation (Day 0) to the first of 7 consecutive days with platelet count ≥20×10⁹/L without transfusion support.
Measured: up to Day 100
Time to Neutrophil Engraftment
Time from transplantation (Day 0) to the first of 3 consecutive days with absolute neutrophil count (ANC) ≥0.5×10⁹/L.
Measured: up to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Jan 2025
- Primary completion1 May 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donghua Zhang, Tongji Hospital
- Investigators
- wen, Principal investigator, Tongji Hospital Affiliated to Tongji Medical College of Huaz- hong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747246
- Sponsor's protocol ID
- DHZ1962-R
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient privacy and institutional policy.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Clinical Study on the Efficacy and Safety of Romiplostim for Promoting Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07747246
- Acronym / sponsor ID
- DHZ1962-R
- Conditions
- Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 5 Aug 2026 (actual)
- 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.
This is a retrospective observational study evaluating the efficacy and safety of romiplostim for promoting platelet engraftment in patients who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) at Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology between January 2025 to May 2026. Medical records were reviewed to collect data on platelet recovery time, transfusion requirements, and adverse events. The primary endpoint was time to platelet engraftment. Secondary endpoints included platelet recovery kinetics, transfusion requirements, transplant-related complications, and safety outcomes.No interventions were assigned as part of this study.
Detailed description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an important curative treatment for various hematological malignancies and non-malignant hematological disorders. However, delayed platelet engraftment remains a frequent complication after transplantation and is associated with prolonged thrombocytopenia, increased bleeding risk, higher transfusion requirements, and extended hospitalization.
Romiplostim, a thrombopoietin receptor agonist (TPO-RA), promotes megakaryocyte proliferation, differentiation, and platelet production through activation of the thrombopoietin receptor (c-Mpl). Although romiplostim has been widely used in immune thrombocytopenia and chemotherapy-induced thrombocytopenia, its efficacy and safety in promoting platelet engraftment after allo-HSCT remain unclear.
The investigators retrospectively analyzed patients who underwent allo-HSCT at Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology between January 2025 to May 2026. Patients were categorized into a romiplostim group and a control group according to whether romiplostim was administered after transplantation.
To minimize baseline imbalance and potential confounding factors, propensity score matching (PSM) was performed at a 1:1 ratio.
The primary endpoint was time to platelet engraftment. Secondary endpoints included platelet recovery kinetics, transfusion requirements, transplant-related complications, and safety outcomes.
Kaplan-Meier analysis with log-rank testing and Cox proportional hazards regression models were performed to evaluate factors associated with platelet engraftment.
Inclusion Criteria:
- Patients diagnosed with AA, AL, MDS, PMF, or other hematologic diseases according to internationally accepted diagnostic criteria
- Patients who underwent allo-HSCT during the study period
- Patients with complete clinical characteristics, transplantation records, and follow-up data
Exclusion Criteria:
- Primary graft failure;
- Death before hematopoietic engraftment
- Missing key clinical data;(4) Use of thrombopoietin receptor agonists other than romiplostim
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Romiplostim Group | – | –Patients who received romiplostim after allogeneic hematopoietic stem cell transplantation for platelet engraftment. |
| Control Group | – | –Patients who did not receive romiplostim after allogeneic hematopoietic stem cell transplantation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent allo-HSCT at Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology (Wuhan, China) from January 2025 to May 2026.
Key inclusion criteria (3 listed)
- Patients diagnosed with AA, AL, MDS, PMF, or other hematologic diseases according to internationally accepted diagnostic criteria
- Patients who underwent allo-HSCT during the study period
- Patients with complete clinical characteristics, transplantation records, and follow-up data
Key exclusion criteria (3 listed)
- Primary graft failure;
- Death before hematopoietic engraftment
- Missing key clinical data;(4) Use of thrombopoietin receptor agonists other than romiplostim
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Platelet Recovery to ≥50×10⁹/L
Time frame: up to Day 100
Time from allogeneic hematopoietic stem cell transplantation (Day 0) to the first date of achieving platelet count ≥50×10⁹/L without transfusion support in the preceding 7 days.
2 secondary outcomes
Time to Platelet Engraftment
Time frame: up to Day 100
Time to Neutrophil Engraftment
Time frame: up to Day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient privacy and institutional policy.
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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.
wen principal investigator
Tongji Hospital Affiliated to Tongji Medical College of Huaz- hong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia, run by Tongji Hospital at 1 site 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Platelet Recovery to ≥50×10⁹/L (time frame: up to Day 100). 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 5 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.