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

Launched by ANHUI PROVINCIAL CHILDREN'S HOSPITAL · Dec 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called dolasetron to prevent nausea and vomiting in children with acute lymphoblastic leukemia (ALL) who are undergoing chemotherapy. The goal is to see how well dolasetron works in managing these side effects during the first five days after starting treatment. Researchers will observe how well participants handle nausea and vomiting and monitor their safety for up to seven days after receiving the medication.

To be eligible for this trial, children aged 2 to 17 years old who have been diagnosed with ALL and are about to start their first round of chemotherapy may participate. Important criteria include a good health status (score of 0-2 on a performance scale) and the ability of the child or their guardian to keep a diary about the treatment. However, children who are allergic to dolasetron or have certain heart conditions will not be included. Participants can expect to have their nausea and vomiting monitored closely, and their overall health and treatment details will be recorded throughout the study.

Gender

ALL

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.