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
This trial does not accept healthy volunteersQualifiers
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 population
Nausea and vomiting induced by induction chemotherapy in children with acute lymphoblastic leukemia
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Dolasetron mesylate injection
Drug1.8 mg/kg Dolasetron mesylate injection should be injected intravenously 30±10 min before chemotherapy infusion, with the maximum dose not exceeding 100 mg. It can also be mixed with apple juice or apple-grape juice for oral use, the oral dose is 1.8 mg/kg, the maximum amount is not more than 100 mg, taken orally within 1 h before chemotherapy. Other antiemetic drugs, except dolasetron, are at the discretion of the subject's supervising physician in accordance with clinical practice.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Use of dolasetron mesylate injection to prevent nausea and vomiting induced by chemotherapy1 intervention
Trial outcomes
Primary outcomes
1
Response (CR) rate during 0-120 hour after chemotherapy (global phase)
CR defined as no vomiting or retching occurring within 120 hours after chemotherapy and no remedial medication being used
Time frame
0-120 hour after chemotherapySecondary outcomes
1
Response (CR) rate 0-24 hour after chemotherapy (acute phase)
CR defined as no vomiting or retching occurring within 24 hours after chemotherapy and no remedial medication being used
Time frame
0-24 hour after chemotherapy2
Response (CR) rate 24-120 hour (delayed period) after chemotherapy
CR defined as no vomiting or retching occurring within 24-120 hours after chemotherapy and no remedial medication being used
Time frame
24-120 hour after chemotherapy3
Proportion of subjects who did not vomit at 0-24 hour and 24-120 hour after chemotherapy
Data were derived from subjects' diaries；Vomiting defined as even when very small amounts of stomach contents are expelled or retching （muscle movements in which vomiting occurs but stomach contents are not expelled)
Time frame
0-24 hour and 24-120 hour after chemotherapy4
Proportion of subjects who did not use rescue treatment 0-24 hour and 24-120 hour after chemotherapy
Data were derived from subjects' diaries；Rescue treatment includes commonly used antiemetic drugs, decided by the investigator
Time frame
0-24 hour and 24-120 hour after chemotherapySponsors and contacts
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Source ClinicalTrials.gov