Dolasetron for the Prevention of CINV in Children With Acute Lymphoblastic Leukemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-17
SponsorAnhui Provincial Children's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Allergic to Dolasetron mesylate injection and its excipients
Patients with prolonged QTc interval (QT interval ≥460 ms)
Other conditions considered by the researchers not to be included in the group.
Trial design
Treatments tested in this trial
- Dolasetron mesylate injection
Treatment groups
500 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov