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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2014

Interventions

  • Drug: ramosetron

Arms, Groups and Cohorts

  • Experimental: ramosetron

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: within 1 week after the end of conditioning regimen

Secondary Measures

  • the efficacy of second dose of ramosetron for the treatment of breakthrough emesis
    • Time Frame: within 1 week after the end of conditioning regimen

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Catholic University of Korea
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ki-Seong Eom, MD, Associate Professor – The Catholic University of Korea

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