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Romiplostim N01 for Platelet Recovery After Haploidentical HSCT

RecruitingPhase 1Ages 18 Years - anyAllFirst Affiliated Hospital of Zhejiang University
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In plain words

What the trial is, and whether it could suit you

This is a prospective, randomized, controlled clinical study designed to evaluate the efficacy and safety of Romiplostim N01 in promoting platelet engraftment after haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) in patients with hematologic malignancies. A total of 130 patients who undergo haplo-HSCT for acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or other hematologic malignancies will be enrolled and randomized 1:1 into a treatment group and a control group. The treatment group will receive Romiplostim N01 subcutaneously once weekly at a starting dose of 5 ยตg/kg, with dose adjustments based on platelet counts (maximum 10 ยตg/kg), for up to 4 weeks or until platelet counts reach โ‰ฅ100 ร— 10โน/L. The control group will not receive rh-TPO or any thrombopoietin receptor agonist (TPO-RA) therapy. Supportive care including transfusions and growt

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Patients with malignant hematologic diseases scheduled to undergo haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) Age โ‰ฅ18 years, male or female. ECOG performance status 0-1. Estimated life expectancy \>6 months. Adequate renal function, defined as:serum creatinine โ‰ค1.5 ร— upper limit of normal (ULN);Blood urea nitrogen (BUN) โ‰ค1.5 ร— ULN. Adequate hepatic function, defined as:Alanine aminotransferase (ALT) โ‰ค2 ร— ULN.Aspartate aminotransferase (AST) โ‰ค2 ร— ULN.Total bilirubin โ‰ค1.5 ร— ULN. Ability to understand and sign informed consent, and willingness to comply with all study requirements. Exclusion Criteria: Uncontrolled active infection or other active malignancy that could interfere with study participation. Severe cardiovascular disease, including:New York Heart Association (NYHA) Class III-IV heart failure;Uncontrolled hypertension or hypotension;History of or high risk for thromboembolic events. Receiving anticoagulation therapy for thrombotic events. Known hypersensitivity to romiplostim or similar agents. Use of rh-TPO or any thrombopoietin receptor agonist (TPO-RA) within 30 days prior to enrollment. Participation in another interventional clinical study within 30 days prior to enrollment. Any other condition that, in the investigator's judgment, makes the patient unsuitable for the study.
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What it tests

  • Romiplostim N01
  • Standard Supportive Care
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Where

1 site
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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