Efficacy Study of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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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 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

Official Title
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Prospective, Single-arm Phase 2 Trial to Evaluate Efficacy and Safety of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation for Hematologic Malignancies

Conditions
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Hematologic Malignancies

Intervention / Treatment
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* Drug: ramosetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing hematopoietic stem cell transplantation conditioned with highly or moderately emetogenic drugs or total body irradiation (TBI) for hematologic malignancies aged over 18 yrs Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 patients who are able to take oral medications patients who get well-informed and sign the consent Exclusion Criteria: 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) Patients complicated by conditions such as gastrointestinal obstruction or active peptic ulcer causing emesis Patients with brain tumor, brain metastasis and epilepsy Patients with the history of extrapyramidal symptom Patients with the history of allergy to serotonin antagonists pregnant or lactating women Patients with drug abuse or psychiatric illness, or patients who are not capable of the normal communications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ramosetron<br> | Drug: ramosetron<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | within 1 week after the end of conditioning regimen | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the efficacy of second dose of ramosetron for the treatment of breakthrough emesis |  | within 1 week after the end of conditioning regimen | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hematologic malignancies, hematopoietic stem cell transplantation, ramosetron, emesis