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Compares treatment options for MDS (Myelodysplastic Syndrome)
Official title Romiplostim Versus rhTPO for Platelet Engraftment After Transplant in MDS and AA
ClinicalTrials.gov ID: NCT07400341
What this study is testing
What is Romiplostim?
Romiplostim is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for mds (myelodysplastic syndrome).
Also referred to as TPO-RA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is for adults aged 18-65 with myelodysplastic syndrome (MDS) or severe aplastic anemia (AA) who are scheduled to receive a donor stem cell transplant (allogeneic hematopoietic stem cell transplant). After the transplant, it is critical for the body to start making its own blood cells again.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 8 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age 18-65 years (inclusive).
- Diagnosis of Myelodysplastic Syndrome (MDS) per WHO criteria, or Severe/Very Severe Aplastic Anemia (SAA/VSAA) per Camitta criteria, and deemed...
- Planned to receive allo-HSCT from a matched sibling, haploidentical, or unrelated donor (including cord blood).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Persistent platelet count \<20×10⁹/L with platelet transfusion dependence between post-transplant days +4 and +10. Transfusion dependence is defined...
You likely can't join if
- Active, uncontrolled bacterial, fungal, or viral infection at the time of enrollment.
- History of arterial thrombosis, or venous thromboembolism within the past 6 months (unless cured or stable for over 6 months).
- Active transplant-associated thrombotic microangiopathy (TA-TMA).
- Pre-transplant bone marrow biopsy showing fibrosis grade ≥ MF-2 (according to WHO criteria).
- Known hypersensitivity to Romiplostim, recombinant human thrombopoietin (rhTPO), or any of their excipients.
- Pregnant or lactating women.
See the full eligibility criteria
- Age 18-65 years (inclusive).
- 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).
- Planned to receive allo-HSCT from a matched sibling, haploidentical, or unrelated donor (including cord blood).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- 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...
- Adequate cardiac, hepatic, and renal function as required for transplantation, per investigator assessment.
- Voluntary participation with written informed consent obtained prior to any study-specific procedures.
- Active, uncontrolled bacterial, fungal, or viral infection at the time of enrollment.
- History of arterial thrombosis, or venous thromboembolism within the past 6 months (unless cured or stable for over 6 months).
- Active transplant-associated thrombotic microangiopathy (TA-TMA).
- Pre-transplant bone marrow biopsy showing fibrosis grade ≥ MF-2 (according to WHO criteria).
- Known hypersensitivity to Romiplostim, recombinant human thrombopoietin (rhTPO), or any of their excipients.
- Pregnant or lactating women.
- 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.
- Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.