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PROMPTRomiplostim vs rhTPO for Platelet Engraftment in MDS and Aplastic Anemia Post-Transplant

Study Aim

This study aims to compare the safety and efficacy of romiplostim and rhTPO in promoting platelet recovery after allo-HSCT in individuals with MDS and Aplastic Anemia, focusing on severe adverse events and platelet engraftment by day +60.

What is being tested

Romiplostim

+ Recombinant Human Thrombopoietin

Drug

Who is being recruted

Bone Marrow Failure Disorders+6

+ Anemia

+ Anemia, Aplastic

From 18 to 65 Years

+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: January 2026

See protocol details

Summary

Principal SponsorThe First Affiliated Hospital of Soochow University

Study ContactDepei Wu Professor, Director of Hematology Department, MDMore contacts

Last updated: February 11, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 31, 2026

Actual date on which the first participant was enrolled.

This clinical trial is a Phase II study comparing the safety and preliminary efficacy of two drugs, romiplostim and recombinant human thrombopoietin (rhTPO), in promoting platelet engraftment after a specific type of stem cell transplant (allo-HSCT) in patients with myelodysplastic syndrome (MDS) or aplastic anemia (AA). The primary goal is to estimate how well these drugs help patients produce new platelets after the transplant, which is crucial for their recovery. This study is important as it aims to find a better treatment option to improve platelet recovery, potentially reducing complications and enhancing the quality of life for patients with MDS or AA. The trial will enroll approximately 74 patients, who will be randomly assigned to either the romiplostim group or the rhTPO group. Patients in the romiplostim group will receive romiplostim injections once weekly, while those in the rhTPO group will receive rhTPO injections once daily. Both treatments start on the 4th day after the transplant and continue until the platelet count reaches a certain level, up to day 60 post-transplant, or for a maximum of 8 weeks. The study's primary outcomes include the time it takes for platelet engraftment and the incidence of severe adverse events within 100 days post-transplant, with a specific focus on graft-versus-host disease (GVHD) and thrombotic events. Safety will be actively monitored throughout the study.

Official TitleA Randomized Phase II Study of Romiplostim vs. rhTPO for Platelet Engraftment After Allo-HSCT in Patients With MDS and Aplastic Anemia (PROMPT)

NCT07400341

Principal SponsorThe First Affiliated Hospital of Soochow University

Study ContactDepei Wu Professor, Director of Hematology Department, MDMore contacts

Last updated: February 11, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

66 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone Marrow Failure DisordersAnemiaAnemia, AplasticAnemia, RefractoryAnemia, Refractory, with Excess of BlastsBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesMyelodysplastic Syndromes

Criteria

7 inclusion criteria required to participate

Persistent platelet count <20×10⁹/L with platelet transfusion dependence between post-transplant days +4 and +10. Transfusion dependence is defined as platelet count not doubling within 24-48 hours after transfusion or ongoing need for prophylactic transfusion.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Age 18-65 years (inclusive).

Adequate cardiac, hepatic, and renal function as required for transplantation, per investigator assessment.

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8 exclusion criteria prevent from participating

Pre-transplant bone marrow biopsy showing fibrosis grade ≥ MF-2 (according to WHO criteria).

Active, uncontrolled bacterial, fungal, or viral infection at the time of enrollment.

Known hypersensitivity to Romiplostim, recombinant human thrombopoietin (rhTPO), or any of their excipients.

Active transplant-associated thrombotic microangiopathy (TA-TMA).

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will receive subcutaneous Romiplostim injections at a starting dose of 5.0 µg/kg once weekly, beginning on transplant day +4. The dose will be adjusted weekly based on platelet counts. Treatment continues until the platelet count is ≥50×10⁹/L without transfusion for 7 days, until day +60 post-transplant, or for a maximum of 8 weeks, whichever occurs first.

Group II

Active Comparator

Participants will receive subcutaneous rhTPO injections at a fixed dose of 15000 U once daily, beginning on transplant day +4. Treatment continues until the platelet count is ≥50×10⁹/L without transfusion for 7 days, until day +60 post-transplant, or for a maximum of 8 weeks, whichever occurs first.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The First Affiliated Hospital of Soochow University, Department of Hematology

Suzhou, ChinaOpen The First Affiliated Hospital of Soochow University, Department of Hematology in Google Maps

Recruiting soonOne Study Center