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

NCT06756022 | Recruiting

• 1 other identifier: EYLL-2024-036
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chemotherapy Induced Nausea and Vomiting

Outcome Measures

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

  0-120 hour after chemotherapy

Secondary Outcomes (7)

• Response (CR) rate 0-24 hour after chemotherapy (acute phase)

  0-24 hour after chemotherapy

• Response (CR) rate 24-120 hour (delayed period) after chemotherapy

  24-120 hour after chemotherapy

• Proportion of subjects who did not vomit at 0-24 hour and 24-120 hour after chemotherapy

  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

  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)

  0-120 hour after chemotherapy

Study Arms (1)

Use of dolasetron mesylate injection to prevent nausea and vomiting induced by chemotherapy

Subjects with childhood acute lymphoblastic leukemia treated with dolasetron mesylate injection for the prevention of nausea and vomiting induced by induction chemotherapy

Drug: Dolasetron mesylate injection

Interventions

Dolasetron mesylate injection DRUG

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.

Use of dolasetron mesylate injection to prevent nausea and vomiting induced by chemotherapy

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Nausea and vomiting induced by induction chemotherapy in children with acute lymphoblastic leukemia

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Children's Hospital: lead

Study Sites (1)

Anhui Children's Hospital

Hefei, Anhui, China

RECRUITING

MeSH Terms

Conditions

Vomiting

Interventions

dolasetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tianping Chen

CONTACT

（+86）13855189560; anhuichentp@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: January 1, 2025
• Study Start: November 21, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)