Actively Recruiting
Efficacy and Safety of Romiplostim N01 for Platelet Recovery in Adult Patients with Hematological Malignancies Undergoing Umbilical Cord Blood Transplantation
Led by Anhui Provincial Hospital · Updated on 2024-11-18
34
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Romiplostim N01 for improving platelet recovery after umbilical cord blood transplantation (UCBT) in patients with hematological malignancies. This Phase II trial focuses on adults aged 18 and older who have undergone UCBT, addressing the common complication of persistent low platelet counts after transplantation, which is critical for transplant success. Participants will receive Romiplostim N01, a long-acting thrombopoietin receptor agonist, administered by subcutaneous injection once weekly from day 1 to day 28 after UCBT. The starting dose is 5 b5g/kg, with a maximum single dose of 250 b5g, for a total of four doses. Depending on platelet levels, dosing may continue, be switched, or discontinued after 28 days. Throughout the study, participants will be monitored for platelet engraftment and recovery, including the time to platelet engraftment and cumulative incidence at 28 days post-transplant. Additional evaluations include granulocyte lineage engraftment, megakaryocyte levels in bone marrow, and total platelet transfusions over four weeks. Safety and adverse events will be tracked, with the trial planned to enroll 34 patients. The trial duration and follow-up align with the 28-day treatment and observation period after transplantation.
CONDITIONS
Brief Title
Romiplostim N01 for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing UCBT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 years or older, male or female
- Diagnosed with hematological malignancies
- Undergoing umbilical cord blood transplantation
- ECOG performance status score of 0 to 2
- Voluntarily agree to participate and sign informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Known allergy to Romiplostim N01
- History of severe thrombotic events or active thromboembolism requiring anticoagulation
- History of platelet dysfunction or severe bleeding within 7 days before screening
- Chronic active hepatitis B or C infection
- Previous repeat, multiple, or multiple organ transplantation
- Positive for HIV, EBV-DNA, or CMV-DNA
- Severe infection or serious heart, liver, lung, kidney, neurological, or metabolic diseases
- Serious adverse events (Level 4 or 5) before treatment
- Participation in another clinical trial with exploratory drugs or devices within 30 days prior to baseline
- Cognitive impairment or uncontrolled mental illness
- Refusal to receive Romiplostim N01 treatment by participant or authorized family
- Judged unsuitable by researchers due to medical history or anticipated non-adherence due to financial issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 28 days
Participants receive Romiplostim N01 subcutaneously once weekly from Day +1 to Day +28 after umbilical cord blood transplantation to support platelet recovery.
4 weekly visits (in-person)
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China, 230036
Actively Recruiting
Research Team
X
Xiaoyu Zhu, ph.D
W
Wanjie Wang, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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