NCT06756022 Dolasetron for the Prevention of CINV in Children With Acute Lymphoblastic Leukemia
| NCT ID | NCT06756022 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Anhui Provincial Children's Hospital |
| Condition | Chemotherapy Induced Nausea and Vomiting |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-11-21 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2024-11-21 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06756022 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 17 Years, studying Chemotherapy Induced Nausea and Vomiting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06756022 currently recruiting?
Yes, NCT06756022 is actively recruiting participants. Contact the research team at anhuichentp@163.com for enrollment information.
Where is the NCT06756022 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT06756022 clinical trial?
NCT06756022 is sponsored by Anhui Provincial Children's Hospital. The trial plans to enroll 500 participants.