Using Dolasetron to Prevent Nausea and Vomiting in Children with Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study involves 500 children aged 2 to 17 years diagnosed with acute lymphoblastic leukemia who will receive dolasetron mesylate injection to prevent chemotherapy-induced nausea and vomiting. Participants will be monitored for nausea and vomiting control within 120 hours after chemotherapy and for safety within 7 days post-treatment. Data on demographics, medical history, and treatment responses will be collected to evaluate the effectiveness of dolasetron in this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Anhui Children's Hospital
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Tianping Chen
• Email: anhuichentp@163.com
• Phone: （+86）13855189560

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.