A Phase 2 interventional study of Romiplostim and Best Supportive Care (BSC) in Hematologic Diseases, sponsored by Liping Dou. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Liping Dou · Phase 2, Interventional, and Treatment
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.
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.
609 studies on the registry are indexed under Hematologic Diseases; 108 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 410 interventional studies indexed under Hematologic Diseases.
Browse Hematologic Diseases studies →Liping Dou is the lead sponsor of 13 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive romiplostim and supportive care after allogeneic hematopoietic stem cell transplantation.
Drug: Romiplostim
Participants will receive close monitoring and best supportive care after allogeneic hematopoietic stem cell transplantation.
Other: Best Supportive Care (BSC)
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.
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.
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.
Time frame: Day +30 after allo-HSCT
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.
Time frame: From transplantation (Day 0) through Day +60
Time to Neutrophil Engraftment
Time from allogeneic hematopoietic stem cell transplantation to neutrophil engraftment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From transplantation (Day 0) through Day +100
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Romiplostim
Liping Dou