Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Induced Nausea and Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dolasetron mesylate injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Use of dolasetron mesylate injection to prevent nausea and vomiting induced by chemotherapy
- description
- Subjects with childhood acute lymphoblastic leukemia treated with dolasetron mesylate injection for the prevention of nausea and vomiting induced by induction chemotherapy
- interventionNames
- Drug: Dolasetron mesylate injection
Primary outcomes (1)
- measure
- Response (CR) rate during 0-120 hour after chemotherapy (global phase)
- timeFrame
- 0-120 hour after chemotherapy
- description
- CR defined as no vomiting or retching occurring within 120 hours after chemotherapy and no remedial medication being used
Secondary outcomes (7)
- measure
- Response (CR) rate 0-24 hour after chemotherapy (acute phase)
- timeFrame
- 0-24 hour after chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available