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

Last updated: December 30, 2024
Sponsor: Anhui Provincial Children's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stomach Discomfort

Colic

Vomiting

Treatment

Dolasetron mesylate injection

Clinical Study ID

NCT06756022
EYLL-2024-036
  • Ages 2-17
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Age 2~17 years old

  2. The diagnosis of acute lymphoblastic leukemia was analyzed by comprehensiveexamination of bone marrow cell morphology, immune typing, cytogenetics andmolecular 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 toGuidelines 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

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.

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Dolasetron mesylate injection
Phase:
Study Start date:
November 21, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Anhui Children's Hospital

    Hefei, Anhui
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.