Actively Recruiting
Romiplostim N01 for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing UCBT
Led by Anhui Provincial Hospital · Updated on 2024-11-18
34
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of Romiplostim N01 for platelet recovery after umbilical cord blood transplantation (UCBT) in patients with hematological malignancies.
CONDITIONS
Official 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 and undergoing umbilical cord blood transplantation
- ECOG performance status of 0 to 2
- Voluntary participation with full understanding and signed informed consent
You will not qualify if you...
- Pregnant or lactating women
- Known allergy to Romiplostim N01
- History of severe thrombotic events or active thromboembolism requiring anticoagulation
- History of platelet dysfunction, bleeding-prone disease, or severe bleeding within 7 days prior to screening
- Chronic active hepatitis B or C
- Repeat or multiple transplantation or multiple organ transplantation
- HIV positive, EBV-DNA positive, or CMV-DNA positive
- Severe infection or serious heart, liver, lung, kidney, neurological, or metabolic diseases
- Serious adverse event (Level 4 or 5) during pre-treatment period
- Participation in another clinical study with exploratory drug/device within 30 days prior to baseline
- Cognitive impairment or uncontrolled mental illness
- Refusal to receive Romiplostim N01 treatment
- Judged unsuitable by researchers due to medical history or adherence concerns
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
W
Wanjie Wang, M.D
CONTACT
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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