Dolasetron for the Prevention of CINV in Children With Acute Lymphoblastic Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dolasetron mesylate injection.
- Who it may be relevant to
- Registry conditions: Chemotherapy Induced Nausea and Vomiting. Basic parameters: 2 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective, Multicenter, Real-world Study of Dolasetron Mesylate Injection for the Prevention of Chemotherapy-induced Nausea and Vomiting in Children With Acute Lymphoblastic Leukemia
Overview
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.
Detailed description
Screening period: D-14\~D0 (D1 recorded on the day of chemotherapy drug infusion)
Subjects who planned to receive induction chemotherapy for the first time signed informed consent for this study, completed screening period examination, checked the inclusion criteria before drug infusion, and successfully screened subjects received CINV（chemotherapy-induced nausea and vomiting） prophylaxis regimen including Dolasetron mesylate injection.
Treatment observation period: D1\~D5 (beginning of study drug administration - 120 h after chemotherapy drug infusion)
Subjects who met all inclusion criteria and did not meet any exclusion criteria were required to complete pre-chemotherapy CINV prophylaxis 30±10 min before induction chemotherapy drug infusion, as described in the administration protocol. The time of starting infusion of chemotherapy drugs (referring to other chemotherapy drugs except hormone drugs in the chemotherapy regimen) was recorded as 0 h, and the subsequent days were calculated as 24 hours.
Within 120 h after the start of chemotherapy infusion, if the subject had at least one episode of vomiting, retching, or nausea and complained of antiemetic therapy, the investigator evaluated the subject and gave remedial antiemetic therapy, which was determined by the investigator.
Within 120 h after the infusion of chemotherapy drugs, the subject or guardian will fill in the occurrence of vomiting/retching and nausea daily through the subject's diary. If there were any omissions in the subjects' diaries, the researchers would remind the subjects to fill in the contents through phone calls and wechat.
Follow-up period: D6\~D7 (or until this discharge, whichever occurs first)
Adverse events were collected from D6 to D7 after chemotherapy drug infusion began (or until this discharge, whichever occurred first), and the relevant data were recorded in the study medical records and EDC（Electronic Data Capture） system.
Interventions
- Drug Dolasetron mesylate injection
1.8 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.
Primary outcome measures
- Response (CR) rate during 0-120 hour after chemotherapy (global phase) [Time frame: 0-120 hour after chemotherapy]
Secondary outcome measures (7)
- Response (CR) rate 0-24 hour after chemotherapy (acute phase) [Time frame: 0-24 hour after chemotherapy]
- Response (CR) rate 24-120 hour (delayed period) after chemotherapy [Time frame: 24-120 hour after chemotherapy]
- Proportion of subjects who did not vomit at 0-24 hour and 24-120 hour after chemotherapy [Time frame: 0-24 hour and 24-120 hour after chemotherapy]
- Proportion of subjects who did not use rescue treatment 0-24 hour and 24-120 hour after chemotherapy [Time frame: 0-24 hour and 24-120 hour after chemotherapy]
- 0-120 h after chemotherapy when vomiting (vomiting or retching) first occurs or rescue treatment is given (whichever occurs first) [Time frame: 0-120 hour after chemotherapy]
- Proportion of subjects free of nausea 0-24 hour and 24-120 hour after chemotherapy [Time frame: 0-24 hour and 24-120 hour after chemotherapy]
- The incidence and severity of adverse events (aes) within 7 days after chemotherapy (or until this discharge, whichever occurs first) [Time frame: 7 days after chemotherapy (or until this discharge, whichever occurs first)]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Anhui Children's Hospital — Hefei
Identifiers
NCT: NCT06756022 · EYLL-2024-036