Clinical trial · Interventional
Efficacy Study of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation
Prospective, Single-arm Phase 2 Trial to Evaluate Efficacy and Safety of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation for Hematologic Malignancies
- 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)
1. The purpose of this study is to determine the efficacy of ramosetron for the prevention of emesis and the control of nausea and vomiting despite of the prophylactic antiemetic treatment during hematopoietic stem cell transplantation 2. The study hypothesis is that ramosetron is effective for the prevention of emesis and control of emesis and/or vomiting that develop after the prophylactic antiemetic therapy in the setting of hematopoietic stem cell transplantation
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 |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ramosetron | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ramosetron
- interventionNames
- Drug: ramosetron
Primary outcomes (1)
- measure
- efficacy of ramosetron in terms of complete response (no emesis, no rescue therapy) during the conditioning regimen and within 3 or 6 days after the end of the conditioning regimen
- timeFrame
- within 1 week after the end of conditioning regimen
Secondary outcomes (1)
- measure
- the efficacy of second dose of ramosetron for the treatment of breakthrough emesis
- timeFrame
- within 1 week after the end of conditioning regimen
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients undergoing hematopoietic stem cell transplantation conditioned with highly or moderately emetogenic drugs or total body irradiation (TBI) for hematologic malignancies 2. aged over 18 yrs 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 4. patients who are able to take oral medications 5. patients who get well-informed and sign the consent Exclusion Criteria: 1. Patients complicating * severe hypertension (systolic blood pressure \> 210 mmHg or diastolic blood pressure \> 120 mmHg) * significant heart disease such as congestive heart failure * renal insufficiency (serum Cr \>= 3.0 mg/dL) * liver disease (Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 3 upper normal limit; alkaline phosphatase (ALP) \> 2 upper normal limit) 2. Patients complicated by conditions such as gastrointestinal obstruction or active peptic ulcer causing emesis 3. Patients with brain tumor, brain metastasis and epilepsy 4. Patients with the history of extrapyramidal symptom 5. Patients with the history of allergy to serotonin antagonists 6. pregnant or lactating women 7. Patients with drug abuse or psychiatric illness, or patients who are not capable of the normal communications
References
Publications (0)
Data not yet available