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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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

Primary outcome measure(s)

• Response (CR) rate during 0-120 hour after chemotherapy (global phase) — 0-120 hour after chemotherapy
  CR defined as no vomiting or retching occurring within 120 hours after chemotherapy and no remedial medication being used

Trial sites (1)