Dolasetron for Preventing Nausea in Children with Leukemia
Dolasetron for the Prevention of CINV in Children With Acute Lymphoblastic Leukemia
Recruiting
Observational Study
Chemotherapy Induced Nausea and Vomiting
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
2 – 17
Sex
Any
Study type
Observational
Participants needed
500 (estimated)
Sponsor
Anhui Provincial Children's Hospital · Other
Who this trial is looking for
This trial is looking for children aged 2 to 17 years who have been diagnosed with acute lymphoblastic leukemia. Participants will receive dolasetron to help prevent nausea and vomiting caused by chemotherapy.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 2 and 17 years old
I have been diagnosed with acute lymphoblastic leukemia
I plan to receive chemotherapy for the first time
I have an ECOG score between 0 and 2
I expect to survive for more than 3 months
I can read and understand a subject diary
You may not be able to join if
I am allergic to dolasetron mesylate injection
I have a prolonged QTc interval (QT interval ≥460 ms)
The researchers have decided I should not be included in the study
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 wi…
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.
Trial Locations
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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, m…
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.
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