Observes dolasetron use to prevent vomiting in children with leukemia
Observes dolasetron, given to prevent chemotherapy nausea and vomiting in children with leukemia.
Plain-language title generated from the registry record
Registry title: Dolasetron for the Prevention of CINV in Children With Acute Lymphoblastic Leukemia
Key facts
- Where
- Hefei, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 17 years old?
Source: NCT06756022, who can take part
Where in China
- Anhui Children's HospitalHefei, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Anhui Provincial Children's Hospital
- Trial code
- NCT06756022
- Record updated
- 1 January 2025
- Original description
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.Read full original descriptionShow less
Prospective, Multicenter, Real-world Study of Dolasetron Mesylate Injection for the Prevention of Chemotherapy-induced Nausea and Vomiting in Children With Acute Lymphoblastic Leukemia
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.
Inclusion: Age 2~17 years old; The diagnosis of acute lymphoblastic leukemia was analyzed by comprehensive examination of bone marrow cell morphology, immune typing, cytogenetics and molecular biology; The subjects plan to receive induced remission therapy such as VDLP/VDLD+CAM, multicenter CCCG ALL 2015 protocol, SCCCG-ALL-2023 protocol, etc. according to Guidelines for Diagnosis and Treatment of Childhood acute lymphoblastic Leukemia (2018 Edition) for the first time; Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2; Expected to survive for more than 3 months; Subject or guardian can read, understand and complete subject diary.
Exclusion: Allergic to Dolasetron mesylate injection and its excipients; Other conditions considered by the researchers not to be included in the group; Patients with prolonged QTc interval (QT interval ≥460 ms).