Weekly shot may beat daily shots for blood recovery after transplant
NCT ID NCT07400341
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a once-weekly injection (romiplostim) can help platelets recover faster and more safely than a daily injection (rhTPO) after a donor stem cell transplant. It includes 66 adults with MDS or severe aplastic anemia. The goal is to reduce bleeding risk and transfusion needs.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-65 years (inclusive). 2. Diagnosis of Myelodysplastic Syndrome (MDS) per WHO criteria, or Severe/Very Severe Aplastic Anemia (SAA/VSAA) per Camitta criteria, and deemed eligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT). 3. Planned to receive allo-HSCT from a matched sibling, haploidentical, or unrelated donor (including cord blood). 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. 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. 6. Adequate cardiac, hepatic, and renal function as required for transplantation, per investigator assessment. 7. Voluntary participation with written informed consent obtained prior to any study-specific procedures. Exclusion Criteria: 1. Active, uncontrolled bacterial, fungal, or viral infection at the time of enrollment. 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 showing fibrosis grade ≥ MF-2 (according to WHO criteria). 5. Known hypersensitivity to Romiplostim, recombinant human thrombopoietin (rhTPO), or any of their excipients. 6. Pregnant or lactating women. 7. Women of childbearing potential or men with partners of childbearing potential who are unwilling to use highly effective contraception during the study period and for at least 3 months after the last dose of study drug. 8. Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Soochow University, Department of Hematology
RECRUITINGSuzhou, Jiangsu, 215006, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a drug duo keep High-Risk blood cancers at bay after transplant?
- Can a new pill boost the power of an existing leukemia treatment?
- Personalized dosing may improve stem cell transplant survival in blood cancer patients
- Could bone marrow from deceased donors cure blood cancers?
- New blood test may predict cancer relapse after transplant
- New hope for blood cancer patients: daily pill aims to prevent relapse without transplant