A Randomized Phase II Study of Romiplostim vs. rhTPO for Platelet Engraftment After Allo-HSCT in Patients With MDS and Aplastic Anemia (PROMPT)
Phase: PHASE2
Conditions: MDS (Myelodysplastic Syndrome), Aplastic Anemia (AA)
Sponsor: The First Affiliated Hospital of Soochow University

Efficacy and Safety of Romiplostim vs.
rhTPO in Promoting Platelet
Engraftment after Allo-HSCT in
Patients with MDS and AA
Sponsor: Department of Hematology, The First Affiliated Hospital of Soochow
University
Responsible Department: Department of Hematology
Principal Investigators: Depei Wu / Xiaojin Wu
Protocol Version: V1.0
Version Date: 2025-12-24
Ethics and Compliance Statement
This study protocol will be submitted to the Ethics Committee of The First Affiliated
Hospital of Soochow University for review and approval, and will be registered with
the Chinese Clinical Trial Registry. The study will be conducted in strict compliance
with the Good Clinical Practice (GCP) guidelines, the World Medical Association
Declaration of Helsinki (2013), and relevant Chinese laws and regulations, ensuring
the protection of subjects' rights and safety.
Investigator Statement and Signature Page
As the principal investigator of this study, I will adhere to the ethical principles of the
National Health Commission's "Measures for Ethical Review of Biomedical Research
Involving Humans" (2016), the World Medical Association Declaration of Helsinki
(2013), and the Council for International Organizations of Medical Sciences (CIOMS)
International Ethical Guidelines for Health-related Research Involving Humans
(2016). Under the guidance of Good Clinical Practice (GCP), I will strictly follow the
protocol approved by the Ethics Committee to conduct the study, ensuring scientific
integrity and protecting the health and rights of subjects.
Protocol Synopsis

Study
Objectives
Primary Objectives: To preliminarily evaluate the efficacy of
romiplostim in promoting platelet engraftment after allo-HSCT
(parameter estimation) and to assess its safety (incidence of ≥
Grade 3 AEs within 100 days).
Secondary Objectives: To compare platelet engraftment time,
60-day engraftment rate, platelet transfusion requirements, and
survival differences (OS, PFS, NRM) between the two groups.
Sample Size
Total of 66 evaluable subjects, randomized 1:1 (33 in romiplostim
group, 33 in rhTPO group). Considering dropout rate,
approximately 74 subjects planned for enrollment.
Study
Population
Patients aged 18-65 years, diagnosed with MDS or severe/very
severe AA (SAA/VSAA) and eligible for allo-HSCT.
Study Design
Prospective, single-center, randomized, open-label,
parallel-controlled Phase II clinical trial.
Inclusion
Criteria
Key criteria: Age 18-65 years; diagnosed with MDS or
SAA/VSAA; planned for allo-HSCT; platelet count <20×10⁹/L
with transfusion dependence between day +4 and +10
post-transplant; ECOG performance status 0-2; signed informed
consent.
Exclusion
Criteria
Key criteria: Uncontrolled active infection; specific history of
thrombosis; active TA-TMA; bone marrow fibrosis ≥MF-2 grade;
allergy to study drugs; pregnancy/lactation, etc.
Intervention
Experimental Group: Romiplostim, starting dose 5.0 µg/kg,
subcutaneous injection, once weekly, with dose adjustment based
on platelet counts.
Control Group: rhTPO, 15000 U, subcutaneous injection, once
daily.
Treatment Duration: Starting from day +4 post-transplant, until
platelet count ≥50×10⁹/L sustained for 7 days, or until day +60,
maximum 8 weeks.
Primary
Endpoints
1. Platelet engraftment time (first achievement of ≥20×10⁹/L
without platelet transfusion for 7 consecutive days)
2. Incidence of ≥Grade 3 adverse events (AEs) within 100 days
post-transplant
Secondary
Endpoints
60-day platelet engraftment rate (≥50×10⁹/L), total platelet
transfusion units (days 0-60), overall survival (OS),
progression-free survival (PFS), non-relapse mortality (NRM).

Study
Timeline
Screening period (pre-transplant), treatment period (day +4 to day
+60), primary follow-up period (to day +100), long-term follow-up
period (to 2 years post-transplant).
Statistical
Methods
Primary endpoints: Engraftment time analyzed using Kaplan-Meier
method and Log-rank test; incidence of ≥Grade 3 AEs analyzed
using Fisher's exact test. Secondary endpoints: Categorical
variables analyzed using Fisher's exact test or χ² test; continuous
variables using Wilcoxon rank-sum test; survival analysis using
Kaplan-Meier method. Full Analysis Set (FAS) as primary analysis
set.
Publication
Plan
Results will be published in peer-reviewed international scientific
journals and presented at relevant academic conferences.
1. Study Background
Myelodysplastic syndrome (MDS) and aplastic anemia (AA) are two important
categories of hematopoietic failure disorders. Allogeneic hematopoietic stem cell
transplantation (allo-HSCT) is an effective and potentially curative treatment for
intermediate/high-risk MDS and severe AA patients who have failed or relapsed after
immunosuppressive therapy (IST). Approximately 5% to 37% of patients may
experience delayed platelet engraftment (DPE) or secondary thrombocytopenia,
leading to increased non-relapse mortality and significantly reduced overall survival.
This not only significantly increases bleeding risk, transplant-related mortality (TRM),
and healthcare costs, but also severely impacts patients' quality of life and overall
survival (OS).
Studies have shown that 69% of patients receiving myeloablative conditioning
achieve platelet recovery within 60 days. Platelet and immune function recovery are
closely related to treatment-related mortality and overall survival (OS). However,
there is currently a lack of reliable and effective methods to improve platelet recovery
and prevent DPE. Intravenous immunoglobulin, corticosteroids, repeated platelet
transfusions, and rituximab remain important treatment approaches, mostly based on
small-scale studies or case reports, lacking high-level evidence support. These
methods are associated with higher costs and infection risks and may affect patients'
quality of life.
Thrombopoietin (TPO) is the most critical cytokine regulating megakaryocyte
differentiation and platelet production. In China, it has been widely used clinically,
particularly in AA and chemotherapy-induced thrombocytopenia (CIT). Some studies
have shown that it can promote platelet recovery and reduce transfusion requirements
after allogeneic transplantation (such as haploidentical or cord blood transplantation).
However, its efficacy remains controversial, especially in the autologous
transplantation setting, where some studies have shown that it did not significantly
accelerate platelet engraftment and instead increased medical costs. Its daily or
every-other-day injection regimen also poses inconvenience for post-transplant
outpatient management.

Unique Advantages of Romiplostim:
1. Mechanism of Action: Romiplostim is a peptide body molecule with no
sequence homology to endogenous TPO. It binds to different epitopes of the
TPO receptor transmembrane region, activating downstream signaling
pathways, theoretically allowing synergistic or additive effects with rhTPO.
2. Pharmacokinetic Advantage: Long-acting formulation requiring only
once-weekly subcutaneous injection, greatly improving dosing convenience
and patient compliance, particularly suitable for long-term management of
post-transplant discharged patients.
3. Preliminary Evidence: Proven effective in immune thrombocytopenia (ITP)
and chemotherapy-induced thrombocytopenia (CIT). Preliminary studies by
Scordo et al. (2023) showed that while romiplostim did not shorten platelet
engraftment time after autologous transplantation, it significantly increased
post-engraftment platelet counts, demonstrating good biological activity and
safety.
This study selects MDS patients requiring allo-HSCT (covering different risk groups)
and AA patients who have failed first-line non-transplant therapy as the study
population, based on the following considerations:
1. Clear Clinical Need: This population has a high incidence of post-transplant
DPE, and there is currently a lack of unified, effective preventive or treatment
measures, representing a clear unmet clinical need.
2. Disease Biology and Risk Balance: Both MDS and AA share
pathophysiological backgrounds of hematopoietic stem cell defects and bone
marrow failure, posing significant challenges for post-transplant hematopoietic
reconstitution. This study will control potential impacts of different disease
subtypes on outcomes through strict inclusion/exclusion criteria (such as
excluding patients with severe pre-transplant bone marrow fibrosis) and
stratified randomization. Simultaneously, the potential risk of TPO-RA
stimulating clonal evolution will be carefully assessed as an important safety
monitoring point across the entire MDS population, not limited to low-risk
groups, which will provide more comprehensive safety evidence for this class
of drugs.
3. Treatment Convenience Need: Post-transplant management is complex, and
the long-acting dosing regimen of romiplostim has significant potential in
improving patient compliance and simplifying outpatient management.
Although TPO-RAs show promising application prospects, there is currently a lack of
prospective, controlled study data on romiplostim in allogeneic hematopoietic stem
cell transplantation, particularly in MDS and AA patients. Its safety, especially
potential impacts on graft-versus-host disease (GVHD) occurrence and development
(due to its possible modulation of immune cell function), and whether it increases
thrombotic event risks are key questions that this study needs to address.
Therefore, this study aims to evaluate the efficacy and safety of romiplostim
compared with rhTPO in promoting platelet engraftment after allo-HSCT in MDS and
AA patients through a prospective, single-center, randomized controlled clinical trial,

with the goal of providing a new, potentially superior treatment option for clinical
practice.
2. Study Objectives
Primary Objectives
1. Preliminary Efficacy Estimation: To preliminarily evaluate the efficacy of
romiplostim in promoting platelet engraftment, providing parameter
estimation for subsequent studies.
2. Safety: To assess the incidence of ≥Grade 3 adverse events (AEs) within 100
days, including: GVHD (graded according to NIH criteria), thrombotic events
(TA-TMA, deep vein thrombosis, etc.).
Secondary Objectives
1. To compare differences between the two groups in platelet engraftment time
(first achievement of ≥20×10⁹/L without platelet transfusion for 7 consecutive
days), 60-day platelet engraftment rate (≥50×10⁹/L), and platelet transfusion
requirements (total units from day 0 to day 60).
2. To evaluate differences between the two groups in overall survival (OS),
progression-free survival (PFS), and non-relapse mortality (NRM).
Exploratory Objectives

Immune reconstitution (lymphocyte subsets, such as CD4+/CD8+ T cells, NK
cells, B cell counts)

Megakaryocyte-related biomarkers (total megakaryocyte count
CD41+/CD61+, maturity CD41+/CD61+/CD36+, TPO levels at
post-transplant day +14, +28, or when platelet recovery is delayed)

Pharmacoeconomic evaluation (comparison of total hospitalization costs, drug
costs, and cost-effectiveness between the two groups)
3. Study Rationale
3.1 Research Foundation
Mechanistic Studies: Romiplostim is a peptide body TPO receptor agonist with no
sequence homology to endogenous TPO. It promotes megakaryocyte differentiation
and platelet production by activating TPO receptor downstream signaling pathways,
with its mechanism validated in preclinical models.
Preclinical and Clinical Literature: Multiple studies have shown that rhTPO can
promote platelet engraftment after allo-HSCT (e.g., Han et al., 2015; Wang et al.,
2017). Romiplostim has been proven effective in immune thrombocytopenia (ITP)

and chemotherapy-induced thrombocytopenia (CIT) (Scordo et al., 2023), but its
application in allo-HSCT still lacks prospective controlled studies.
3.2 Subject Selection
Disease Background: MDS and AA patients have a high incidence of delayed
platelet engraftment (DPE) after transplantation (5%-37%), and there is currently a
lack of unified effective interventions, representing a clear clinical need.
Pathophysiological Commonality: Both involve hematopoietic stem cell defects and
bone marrow failure, with similar challenges for post-transplant hematopoietic
reconstitution.
Risk Control: Exclusion of patients with bone marrow fibrosis ≥MF-2 grade before
transplantation to reduce disease heterogeneity impact. Stratified randomization by
disease type (MDS vs. AA) to control prognostic factors. Inclusion of MDS patients
across different risk groups to comprehensively assess potential clonal evolution risks
of TPO-RAs.
3.3 Dose and Administration
Romiplostim Dose: Starting dose of 5.0 µg/kg (once weekly) is based on its common
dosing in ITP and CIT and exploratory studies by Scordo et al. (2023) in
post-transplant patients.
Dose adjustment is based on dynamic platelet counts, aiming to maintain platelets
within a safe range (≥20×10⁹/L) while avoiding excessive elevation that could trigger
thrombotic risks.
rhTPO Dose: 15000 U per dose once daily is the standard clinical practice in China,
consistent with the drug label and previous transplantation study protocols.
Administration Timing: Starting from day +4 post-transplant, covering the critical
period for platelet engraftment, continuing until platelet count ≥50×10⁹/L or for a
maximum of 8 weeks.
3.4 Endpoint Selection
Primary Endpoints:

Incidence of ≥Grade 3 AEs within 100 days: Focuses on safety assessment,
particularly transplant-related complications such as GVHD and thrombotic
events.

Platelet engraftment time: Directly reflects the drug's efficacy in promoting
platelet recovery.
Secondary Endpoints:


60-day platelet engraftment rate, transfusion requirements: Assess short-term
efficacy and clinical burden.

OS, PFS, NRM: Assess impact on long-term prognosis.
Exploratory Endpoints: Include immune reconstitution, biomarkers,
pharmacoeconomics, providing preliminary data for mechanism and health economics
research.
3.5 Risk-Benefit Assessment
Risks:

Clonal evolution risk: TPO-RAs may stimulate malignant clone proliferation,
particularly requiring close monitoring in MDS patients.

Thrombotic risk: Excessive platelet elevation may increase thrombotic events.

GVHD risk: TPO-RAs may affect immune function, requiring monitoring of
GVHD occurrence and development.

Other AEs: Such as allergic reactions, hepatic/renal function effects, etc.
Risk Control Measures:

Weekly monitoring of platelets, D-dimer, GVHD biomarkers.

Establishment of discontinuation criteria (e.g., new onset of Grade II or higher
aGVHD, thrombotic events, bone marrow fibrosis progression).
Benefits:

Potential acceleration of platelet engraftment, reduced transfusion dependence,
decreased bleeding risks and medical costs.

Long-acting formulation (once weekly) improves patient compliance, suitable
for post-transplant outpatient management.

If effective, could provide a new treatment option for this patient population,
filling a clinical gap.
4. Study Design
4.1 Sample Size Calculation
This is an exploratory Phase II clinical trial aimed at obtaining preliminary efficacy
and safety data. A total of 66 subjects are planned to be enrolled, randomly allocated
1:1 to the experimental group (n=33) and rhTPO control group (n=33).
Calculation Basis: Based on consideration of estimation precision for efficacy
indicators rather than traditional superiority/non-inferiority hypothesis testing.
Referring to recent literature, rhTPO achieves platelet engraftment rates of
approximately 90% in post-transplant patients. This study conservatively estimates
the romiplostim group engraftment rate at 85%.

Under this assumption, calculations show that including 33 evaluable patients per
group would control the 95% confidence interval width for the romiplostim group
platelet engraftment rate at approximately ±12% (i.e., 95% CI: 73% - 97%). This
precision level can provide a valuable preliminary estimate of romiplostim's efficacy.
Note: Considering an approximately 10% dropout rate, approximately 74 subjects are
planned for enrollment to ensure 66 subjects ultimately complete primary endpoint
assessment.
4.2 Study Population Selection
Inclusion Criteria
1. Aged 18-65 years (inclusive).
2. Diagnosed with myelodysplastic syndrome (MDS) according to WHO criteria,
or severe/very severe aplastic anemia (SAA/VSAA) according to Camitta
criteria, and assessed as eligible for allogeneic hematopoietic stem cell
transplantation (allo-HSCT).
3. Planned to receive allo-HSCT from matched sibling, haploidentical, or
unrelated donors (including cord blood).
4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.
5. During days +4 to +10 post-transplant, persistent platelet count <20×10⁹/L
with platelet transfusion dependence (defined as platelet count not doubling
within 24-48 hours post-transfusion or still requiring prophylactic transfusion).
6. Cardiac, hepatic, and renal functions meeting transplantation standards
(specific indicators assessed by investigators).
7. Voluntary participation in this study with signed written informed consent
after full understanding.
Exclusion Criteria
1. Presence of active, uncontrolled bacterial, fungal, or viral infection.
2. History of arterial thrombosis, or venous thromboembolism within the past 6
months (unless cured or stable for over 6 months).
3. Active transplant-associated thrombotic microangiopathy (TA-TMA).
4. Pre-transplant bone marrow biopsy confirming bone marrow fibrosis grade ≥
MF-2 (according to WHO criteria).
5. Known allergy to romiplostim, recombinant human thrombopoietin (rhTPO),
or any of their excipient components.
6. Pregnant or lactating women, or women/men of childbearing potential
planning pregnancy during the study period or within 3 months after last dose,
unwilling to use effective contraception.
7. Any other condition considered by the investigator as unsuitable for study
participation.
Withdrawal Criteria
Subjects meeting any of the following criteria should discontinue study treatment:

1. Occurrence of ≥Grade 3 non-hematological toxicity (according to CTCAE
v5.0 criteria), and investigator judges as possibly related to study drug.
2. Occurrence of ≥Grade 4 hematological toxicity.
3. Occurrence of intolerable ≥Grade 2 non-hematological toxicity, judged by
investigator to require study withdrawal.
4. Occurrence of serious adverse event (SAE), judged by investigator or sponsor
as possibly related to study drug.
5. Pregnancy.
6. Investigator considers that continued study participation may pose
unacceptable risk to subject.
Termination Criteria
Subjects may terminate the study for the following reasons, considered as sample
dropout:
1. Subject or legal representative actively withdraws informed consent.
2. Subject requests withdrawal from treatment or refuses continued follow-up for
any reason (e.g., perceived insufficient efficacy, personal reasons).
3. Study cannot continue due to force majeure (e.g., severe natural disasters) or
unexpected events.
4. Lost to follow-up (defined as consecutive failure to contact subject through
any reserved means).
4.3 Study Flow Diagram
4.4 Subject Grouping and Interventions
Grouping Method
Web-based central randomization system, using stratified block randomization (1:1).
Stratification factor: disease type (MDS vs. AA).

Interventions

Experimental Group: Romiplostim. Starting dose 5.0 µg/kg, subcutaneous
injection, administered on days +4 and +11 post-transplant. From day +18,
dose adjustment based on weekly platelet counts.

Control Group: rhTPO. Fixed dose 15000 U, once daily subcutaneous
injection.
Off-Label Use Statement
The Informed Consent Form must clearly and prominently state that romiplostim is
used as "off-label" in this study, with detailed explanation of its rationale, potential
benefits, and risks.
Concomitant Medications
All patients receive unified standard transplant treatment. Prohibition of other
platelet-promoting drugs (e.g., eltrombopag, lusutrombopag). Drugs affecting platelet
function or counts should be used cautiously and recorded in detail.
Rescue Therapy
In case of serious adverse events, immediately suspend study drug administration and
provide corresponding symptomatic supportive treatment (e.g., platelet transfusion,
anticoagulation, escalated immunosuppression).
5. Study Procedures
5.1 Subject Management
Includes recruitment, informed consent, screening, randomization, compliance
management.
5.2 Safety Evaluation and Risk Control Procedures
Establish comprehensive monitoring system including AE/SAE handling, predefined
discontinuation criteria.
5.3 Efficacy Measurement Procedures
Detailed description of measurement methods and timing for primary and secondary
efficacy indicators.
5.4 Discontinuation/Withdrawal Procedures
Standardized handling procedures for subject discontinuation or withdrawal from
study.

5.5 Blinding and Bias Control
Reiterates open-label design, key endpoints assessed by independent review
committee under blinded conditions.
5.6 Visit Schedule

Screening Period (Pre-transplant)

Treatment Period (Day +4 to Day +60)

Primary Follow-up Period (Day +100)

Long-term Follow-up Period (Up to 2 Years Post-transplant)
6. Safety Monitoring and Adverse Event Management
Original content is complete and can be retained. It is recommended to add a
"Independent Data Safety Monitoring Committee (DSMB)" section, describing its
composition by hematology, transplantation, and statistics experts not involved in the
study, responsible for regularly reviewing cumulative safety data and providing
recommendations to the principal investigator and ethics committee regarding trial
continuation.
6.1 Safety Monitoring System
Routine Monitoring
Monitoring frequency: During treatment period (post-transplant to day +60), once
weekly; from day +60 to day +100, according to visit schedule.
Targeted Monitoring
For known or potential risks, such as thrombotic events, GVHD, clonal
evolution/bone marrow fibrosis risk, immunomodulatory risk, etc.
6.2 Adverse Event (AE) and Serious Adverse Event (SAE)
Management Plan
Includes definitions and grading, management procedures, reporting requirements,
etc.
6.3 Predefined Discontinuation and Intervention Criteria
To control specific risks, study drug must be suspended or permanently discontinued
when the following situations occur:

Graft-versus-host disease (GVHD): New onset of Grade II or higher acute
GVHD


Thrombotic events: D-dimer persistently > 5 times upper limit of normal or
imaging-confirmed diagnosis

Bone marrow fibrosis progression: Bone marrow biopsy confirmation of
progression to MF-1 grade or higher compared to baseline

Other severe toxicities
7. Data Management and Statistical Analysis
7.1 Data Management
Validated electronic data capture (EDC) system will be used for data collection.
Implementation of "independent double data entry" and logical checks, with data
query forms (DQF) to resolve data inconsistencies. All study documents will be kept
strictly confidential, preserved for at least 5 years after study completion as required
by regulations.
7.2 Statistical Analysis Plan
Analysis Sets

Full Analysis Set (FAS): All subjects randomized who received at least one
dose of study drug and have at least one efficacy evaluation, analyzed using
intention-to-treat (ITT) principle.

Per Protocol Set (PPS): Subjects who strictly followed protocol and
completed main phase treatment, used for supportive analysis.

Safety Set (SS): All subjects who received at least one dose of study drug.
Missing Data Handling
For primary endpoint (platelet engraftment time), if subject withdraws before
reaching endpoint, data will be treated as censored. For other continuous variables,
appropriate imputation methods or sensitivity analyses will be selected based on
missing data mechanism.
Statistical Methods

Primary Endpoints: Platelet engraftment time estimated using Kaplan-Meier
method, between-group comparison using Log-rank test. Incidence of ≥Grade
3 AEs within 100 days compared using Fisher's exact test.

Secondary Endpoints: Categorical variables analyzed using Fisher's exact
test or χ² test; continuous variables (e.g., transfusion volume) using Wilcoxon
rank-sum test; survival data (OS, PFS) using Kaplan-Meier method and
Log-rank test.

Statistical Software and Significance Level: Using SPSS (v26.0 or higher)
or R (v4.0 or higher) software. All tests are two-sided, with P value <0.05
considered statistically significant.

8. Quality Control and Quality Assurance
The sponsor/principal investigator will designate monitors to regularly monitor the
study site, checking protocol compliance, informed consent process, data recording
accuracy and completeness. Audits may be conducted when necessary. All research
personnel must receive protocol and GCP training.
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