Hematologic DiseasesPhase 2NCT07919977
Romiplostim for Platelet Engraftment After Haploidentical or Matched Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 2 study testing Romiplostim in people with Hematologic Diseases, run by Liping Dou at 1 site in China.
Trial summary
This prospective, multicenter, randomized controlled Phase II study is designed to evaluate the efficacy and safety of romiplostim for platelet engraftment after haploidentical or HLA-matched unrelated donor allogeneic hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Diseases
- What is being tested?
- Romiplostim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, regardless of sex.
- Undergoing haploidentical or fully HLA-matched unrelated donor allogeneic hematopoietic stem cell transplantation for a hematologic disease.
- No severe allergic predisposition.
- No uncontrolled infection or severe psychological disorder.
- Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN), and bilirubin ≤2 times ULN.
- Renal function: creatinine ≤ULN.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 and an anticipated life expectancy of ≥4 months.
- Voluntary participation, with written informed consent provided by the participant or their legally authorized representative after fully understanding the study, and willingness and ability to comply with and complete all study procedures.
Who cannot join
- Pregnancy or breastfeeding.
- Known hypersensitivity to the study drug or any contraindication to its use.
- Severe hepatic impairment, defined as ALT or AST ≥5 times ULN.
- Smoking or chronic alcohol abuse that may interfere with the evaluation of study results.
- Psychiatric illness or another condition that prevents informed consent from being obtained or precludes cooperation with required treatment and examination procedures.
- Major organ surgery within the preceding six weeks.
- Any other significant medical condition, laboratory abnormality, or psychiatric disorder that, in the investigator's judgment, makes the individual unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Li-Ping Dou, Dr., 86-010-66937232, lipingruirui@163.com
Li-Ping Dou, Dr.
About this study
Official title: A Prospective, Randomized, Controlled Phase II Clinical Trial of Romiplostim for Platelet Engraftment After Haploidentical or Matched Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplantation
This prospective, multicenter, randomized controlled Phase II study is designed to evaluate the efficacy and safety of romiplostim for platelet engraftment after haploidentical or HLA-matched unrelated donor allogeneic hematopoietic stem cell transplantation. Approximately 120 patients aged ≥18 years will be randomized equally to the romiplostim group or the best supportive care group. Romiplostim will be administered subcutaneously at 1 μg/kg once weekly, starting on day +3 after transplantation. The primary outcomes are platelet engraftment rates at days +30 after transplantation.
Read the detailed description
This investigator-initiated, prospective, multicenter, randomized controlled Phase II study is designed to evaluate the efficacy and safety of romiplostim for platelet engraftment after haploidentical or HLA-matched unrelated donor allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Approximately 120 patients with hematologic diseases undergoing allo-HSCT will be enrolled and randomized in a 1:1 ratio to the romiplostim group or the best supportive care group. Eligible participants must meet protocol-defined inclusion criteria, including age ≥18 years, an ECOG performance status of 0-3, an expected survival of ≥4 months, and adequate hepatic and renal function. Patients with uncontrolled infections or other protocol-defined exclusion criteria will not be eligible. Written informed consent will be obtained from all participants before enrollment.
Participants assigned to the romiplostim group will receive romiplostim at a dose of 1 μg/kg by subcutaneous injection once weekly, starting on day +3 after transplantation. Participants in both groups will receive transfusion support and other supportive treatments according to clinical needs and the judgment of treating physicians.
The primary efficacy outcomes are platelet engraftment rates at days +30 after transplantation. Platelet engraftment is defined as a platelet count greater than 20 × 10⁹/L for seven consecutive days without platelet transfusion support.
Secondary outcomes include time to platelet engraftment, time to neutrophil engraftment, disease relapse rate, incidence of graft-versus-host disease (GVHD), non-relapse mortality (NRM), overall survival (OS), and the incidence of grade ≥3 adverse events and laboratory abnormalities.
Safety assessments will include the incidence of adverse events, treatment-related adverse events, and adverse events leading to death, treatment discontinuation, or premature withdrawal from the study.
Blood counts and other laboratory assessments will be monitored according to the protocol-defined schedule. The primary data analysis will be performed after the last enrolled participant completes the treatment period and 3 months of follow-up. All participants will continue long-term follow-up to evaluate survival outcomes and other long-term clinical outcomes.
- Conditions
- Hematologic Diseases
- Being tested
- Romiplostim, Best Supportive Care (BSC)
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomiplostimDrug
Participants receive romiplostim at a dose of 1 μg/kg by subcutaneous injection once weekly starting on day +3 after allo-HSCT, along with transfusion and other supportive care as clinically indicated.
Best Supportive Care (BSC)Other
Participants will receive close monitoring and best supportive care after allogeneic hematopoietic stem cell transplantation, including transfusion support and other supportive treatments according to the clinical judgment and standard practice of treating physicians.
| Study group | Role | What they receive |
|---|---|---|
| Romiplostim Group | Experimental | Participants receive romiplostim and supportive care after allogeneic hematopoietic stem cell transplantation. Receives: Drug: Romiplostim |
| Best Supportive Care Group | Active comparator | Participants will receive close monitoring and best supportive care after allogeneic hematopoietic stem cell transplantation. Receives: Other: Best Supportive Care (BSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Engraftment Rate at Day +30 After Allogeneic Hematopoietic Stem Cell Transplantation
The proportion of participants who achieve platelet engraftment at day +30 after allo-HSCT will be assessed. Platelet engraftment is defined as a platelet count greater than 20×10⁹/L for 7 consecutive days without platelet transfusion support.
Measured: Day +30 after allo-HSCT
Secondary outcomes (7)
Time to Platelet Engraftment
Time from allo-HSCT to platelet engraftment. Platelet engraftment is defined as a platelet count >20 × 10⁹/L for seven consecutive days without platelet transfusion support.
Measured: From transplantation (Day 0) through Day +60
Time to Neutrophil Engraftment
Time from allogeneic hematopoietic stem cell transplantation to neutrophil engraftment.
Measured: From transplantation (Day 0) through Day +60
Relapse Rate
The proportion of participants who experience relapse of their underlying hematologic disease after transplantation during the observation period.
Measured: From transplantation (Day 0) through 1 year
Graft-versus-Host Disease (GVHD）
The proportion of participants who develop graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation during the observation period.
Measured: From transplantation (Day 0) through Day 2 years
Non-Relapse Mortality
The proportion of participants who die without prior relapse of their underlying hematologic disease after transplantation during the observation period.
Measured: From transplantation (Day 0) through 2 years
Overall Survival
Overall survival (OS) is defined as the time from the start of study treatment to death from any cause. Participants who are alive at the end of follow-up will be censored at the date they were last known to be alive. Survival status will be assessed by telephone or in-person visits every 2-3 months after completion of study treatment.
Measured: From transplantation (Day 0) through 2 years
Incidence of Grade 3 or Higher Adverse Events and Laboratory Abnormalities
The number and percentage of participants who experience grade 3 or higher adverse events or laboratory abnormalities during study treatment and at the end-of-treatment visit. Clinically significant laboratory abnormalities will be reassessed until resolution or stabilization.
Measured: From transplantation (Day 0) through Day +100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Jun 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liping Dou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liping Dou, Chinese PLA General Hospital
- Investigators
- Li-Ping Dou, Dr., Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919977
- Sponsor's protocol ID
- S2026-095-01
- Status last verified
- Aug 2026
- First submitted
- 1 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Phase II Clinical Trial of Romiplostim for Platelet Engraftment After Haploidentical or Matched Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07919977
- Acronym / sponsor ID
- S2026-095-01
- Conditions
- Hematologic Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Liping DouUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 5 Nov 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 prospective, multicenter, randomized controlled Phase II study is designed to evaluate the efficacy and safety of romiplostim for platelet engraftment after haploidentical or HLA-matched unrelated donor allogeneic hematopoietic stem cell transplantation. Approximately 120 patients aged ≥18 years will be randomized equally to the romiplostim group or the best supportive care group. Romiplostim will be administered subcutaneously at 1 μg/kg once weekly, starting on day +3 after transplantation. The primary outcomes are platelet engraftment rates at days +30 after transplantation.
Detailed description
This investigator-initiated, prospective, multicenter, randomized controlled Phase II study is designed to evaluate the efficacy and safety of romiplostim for platelet engraftment after haploidentical or HLA-matched unrelated donor allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Approximately 120 patients with hematologic diseases undergoing allo-HSCT will be enrolled and randomized in a 1:1 ratio to the romiplostim group or the best supportive care group. Eligible participants must meet protocol-defined inclusion criteria, including age ≥18 years, an ECOG performance status of 0-3, an expected survival of ≥4 months, and adequate hepatic and renal function. Patients with uncontrolled infections or other protocol-defined exclusion criteria will not be eligible. Written informed consent will be obtained from all participants before enrollment.
Participants assigned to the romiplostim group will receive romiplostim at a dose of 1 μg/kg by subcutaneous injection once weekly, starting on day +3 after transplantation. Participants in both groups will receive transfusion support and other supportive treatments according to clinical needs and the judgment of treating physicians.
The primary efficacy outcomes are platelet engraftment rates at days +30 after transplantation. Platelet engraftment is defined as a platelet count greater than 20 × 10⁹/L for seven consecutive days without platelet transfusion support.
Secondary outcomes include time to platelet engraftment, time to neutrophil engraftment, disease relapse rate, incidence of graft-versus-host disease (GVHD), non-relapse mortality (NRM), overall survival (OS), and the incidence of grade ≥3 adverse events and laboratory abnormalities.
Safety assessments will include the incidence of adverse events, treatment-related adverse events, and adverse events leading to death, treatment discontinuation, or premature withdrawal from the study.
Blood counts and other laboratory assessments will be monitored according to the protocol-defined schedule. The primary data analysis will be performed after the last enrolled participant completes the treatment period and 3 months of follow-up. All participants will continue long-term follow-up to evaluate survival outcomes and other long-term clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Romiplostim Group | Experimental | Drug: RomiplostimParticipants receive romiplostim and supportive care after allogeneic hematopoietic stem cell transplantation. |
| Best Supportive Care Group | Active comparator | Other: Best Supportive Care (BSC)Participants will receive close monitoring and best supportive care after allogeneic hematopoietic stem cell transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years, regardless of sex.
- Undergoing haploidentical or fully HLA-matched unrelated donor allogeneic hematopoietic stem cell transplantation for a hematologic disease.
- No severe allergic predisposition.
- No uncontrolled infection or severe psychological disorder.
- Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN), and bilirubin ≤2 times ULN.
Key exclusion criteria (7 listed)
- Pregnancy or breastfeeding.
- Known hypersensitivity to the study drug or any contraindication to its use.
- Severe hepatic impairment, defined as ALT or AST ≥5 times ULN.
- Smoking or chronic alcohol abuse that may interfere with the evaluation of study results.
- Psychiatric illness or another condition that prevents informed consent from being obtained or precludes cooperation with required treatment and examination procedures.
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 |
|---|---|---|
| RomiplostimParticipants receive romiplostim at a dose of 1 μg/kg by subcutaneous injection once weekly starting on day +3 after allo-HSCT, along with transfusion and other supportive care as clinically indicated. | Drug | Romiplostim Group |
| Best Supportive Care (BSC)Participants will receive close monitoring and best supportive care after allogeneic hematopoietic stem cell transplantation, including transfusion support and other supportive treatments according to the clinical judgment and standard practice of treating physicians. | Other | Best Supportive Care Group |
Primary outcome
Platelet Engraftment Rate at Day +30 After Allogeneic Hematopoietic Stem Cell Transplantation
Time frame: Day +30 after allo-HSCT
The proportion of participants who achieve platelet engraftment at day +30 after allo-HSCT will be assessed. Platelet engraftment is defined as a platelet count greater than 20×10⁹/L for 7 consecutive days without platelet transfusion support.
7 secondary outcomes
Time to Platelet Engraftment
Time frame: From transplantation (Day 0) through Day +60
Time to Neutrophil Engraftment
Time frame: From transplantation (Day 0) through Day +60
Relapse Rate
Time frame: From transplantation (Day 0) through 1 year
Graft-versus-Host Disease (GVHD）
Time frame: From transplantation (Day 0) through Day 2 years
Non-Relapse Mortality
Time frame: From transplantation (Day 0) through 2 years
Overall Survival
Time frame: From transplantation (Day 0) through 2 years
Incidence of Grade 3 or Higher Adverse Events and Laboratory Abnormalities
Time frame: From transplantation (Day 0) through Day +100
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Li-Ping Dou, Dr. study chair
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Romiplostim in people with Hematologic Diseases, run by Liping Dou 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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 6 Nov 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li-Ping Dou, Dr. (86-010-66937232, lipingruirui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet Engraftment Rate at Day +30 After Allogeneic Hematopoietic Stem Cell Transplantation (time frame: Day +30 after allo-HSCT). 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 6 Nov 2026.