NCT06756022Recruiting
Dolasetron for the Prevention of CINV in Children With Acute Lymphoblastic Leukemia
Prospective, Multicenter, Real-world Study of Dolasetron Mesylate Injection for the Prevention of Chemotherapy-induced Nausea and Vomiting in Children With Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov · Last updated 1 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 21 Dec 2024
- Start date
- 21 Nov 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Anhui Provincial Children's Hospital
- NCT number
- NCT06756022
What you commit to
- Study type: Observational
- Planned participants: 500
- From 21 Nov 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergic to Dolasetron mesylate injection and its excipients
- Other conditions considered by the researchers not to be included in the group.
Lab values
- Patients with prolonged QTc interval (QT interval ≥460 ms)
Who the study is looking for
- 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.
Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anhui Children's Hospital Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.