What this Trial Is About

This research aims to evaluate the use of dolasetron mesylate injection to prevent nausea and vomiting caused by chemotherapy in children aged 2 to 17 years with acute lymphoblastic leukemia. It is a prospective, multicenter, real-world study involving 500 participants who are scheduled to receive induction chemotherapy for the first time. The study focuses on monitoring nausea and vomiting control within 120 hours after chemotherapy and assessing safety within 7 days or until discharge, whichever occurs first. Participants will receive dolasetron mesylate injection as a preventive treatment against chemotherapy-induced nausea and vomiting. The injection dose is 1.8 mg/kg administered intravenously 30b110 minutes before chemotherapy, with a maximum dose of 100 mg. Oral administration mixed with apple or apple-grape juice is also possible within 1 hour before chemotherapy. Other antiemetic drugs may be used based on the supervising physician's decision. The study includes a screening period before chemotherapy, a treatment observation period from day 1 to day 5 post-chemotherapy, and a follow-up period from day 6 to 7 or until discharge. During the study, participants or their guardians will keep a daily diary recording any episodes of vomiting, retching, or nausea. Researchers will collect demographic data, history of motion sickness, ECOG performance status, details of anti-tumor therapies, antiemetic regimens, rescue therapy, combined drugs, and adverse events. The primary outcome is the response rate to treatment during the 0 to 120 hours after chemotherapy. Adverse events will be monitored and recorded in electronic medical records and data capture systems throughout the follow-up period.

Dolasetron for the Prevention of CINV in Children With Acute Lymphoblastic Leukemia