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

Primary Purpose

Hematologic Malignancies

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ramosetron
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hematologic Malignancies focused on measuring hematologic malignancies, hematopoietic stem cell transplantation, ramosetron, emesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Catholic Blood & Marrow Transplantation Center, Seoul St Mary's Hospital, the Catholic University of KoreaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ramosetron

Arm Description

Outcomes

Primary Outcome 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

Secondary Outcome Measures

the efficacy of second dose of ramosetron for the treatment of breakthrough emesis

Full Information

First Posted
February 7, 2013
Last Updated
December 5, 2014
Sponsor
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01788605
Brief Title
Efficacy Study of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation
Official Title
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
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancies
Keywords
hematologic malignancies, hematopoietic stem cell transplantation, ramosetron, emesis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ramosetron
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ramosetron
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
the efficacy of second dose of ramosetron for the treatment of breakthrough emesis
Time Frame
within 1 week after the end of conditioning regimen
Other Pre-specified Outcome Measures:
Title
the number of vomiting episodes
Time Frame
within 1 week after the end of conditioning regimen
Title
grade of nausea and need for rescue therapy
Time Frame
within 1 week after the end of conditioning regimen

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Catholic Blood & Marrow Transplantation Center, Seoul St Mary's Hospital, the Catholic University of Korea
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo-Kyung Kim, RN
Phone
82-50-7448-6371
Email
mikaella7@naver.com
First Name & Middle Initial & Last Name & Degree
Ki-Seong Eom, MD
Phone
82-2-2258-6056
Email
dreom@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Jong-Wook Lee, MD

12. IPD Sharing Statement

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

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