Actively Recruiting
Dolasetron for the Prevention of CINV in Children With Acute Lymphoblastic Leukemia
Led by Anhui Provincial Children's Hospital · Updated on 2025-01-01
500
Participants Needed
1
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, multicenter, real-world study of 500 participants with childhood acute lymphoblastic leukemia who are scheduled to receive dolasetron mesylate injection for prophylaxis against chemotherapy-induced nausea and vomiting. This study did not make any decision or process intervention for clinical antitumor therapy. The study plans to observe the control of nausea and vomiting within 120 h (D1-D5) after receiving induction chemotherapy and the safety within 7 days (or until this discharge, whichever occurs first). During the whole study, demographic data, history of motion sickness, ECOG score, complications, name and dosage of anti-tumor therapy drugs, this antiemetic regimen, nausea and vomiting, rescue therapy drugs, combined drugs and adverse events were recorded.
CONDITIONS
Official Title
Dolasetron for the Prevention of CINV in Children With Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 to 17 years old
- Diagnosed with acute lymphoblastic leukemia confirmed by bone marrow cell morphology, immune typing, cytogenetics, and molecular biology
- Planned to receive first induction remission therapy such as VDLP/VDLD+CAM, CCCG ALL 2015 protocol, SCCCG-ALL-2023 protocol, or similar
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-2
- Expected survival longer than 3 months
- Subject or guardian able to read, understand, and complete the subject diary
You will not qualify if you...
- Allergy to dolasetron mesylate injection or its excipients
- Prolonged QTc interval (QT interval 60460 ms)
- Any other conditions the researchers consider unsuitable for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Anhui Children's Hospital
Hefei, Anhui, China
Actively Recruiting
Research Team
T
Tianping Chen
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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