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

Hematologic Malignancies Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01788605
• Other study ID #: CBMTC-supp001
• Status: Recruiting
• Phase: Phase 2
• First received: February 7, 2013
• Last updated: December 5, 2014
• Start date: August 2014
• Est. completion date: February 2015

Study information

• Verified date: December 2014
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hematologic Malignancies
• Neoplasms

Intervention

Drug:
• ramosetron

Locations

Country	Name	City	State
Korea, Republic of	Catholic Blood & Marrow Transplantation Center, Seoul St Mary's Hospital, the Catholic University of Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the number of vomiting episodes		within 1 week after the end of conditioning regimen	No
Other	grade of nausea and need for rescue therapy		within 1 week after the end of conditioning regimen	No
Primary	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	Yes
Secondary	the efficacy of second dose of ramosetron for the treatment of breakthrough emesis		within 1 week after the end of conditioning regimen	Yes