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

Recruitingn/aAges 2 Years - 17 YearsAllAnhui Provincial Children's Hospital
NCT06756022 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 2\~17 years old 2. The diagnosis of acute lymphoblastic leukemia was analyzed by comprehensive examination of bone marrow cell morphology, immune typing, cytogenetics and molecular biology. 3. 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 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2 5. Expected to survive for more than 3 months 6. Subject or guardian can read, understand and complete subject diary. Exclusion Criteria: 1. Allergic to Dolasetron mesylate injection and its excipients 2. Patients with prolonged QTc interval (QT interval ≥460 ms) 3. Other conditions considered by the researchers not to be included in the group.
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What it tests

  • Dolasetron mesylate injection
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Where

1 site
Anhui Children's Hospital
Hefei, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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