Hematologic MalignanciesPhase 2NCT01788605
Efficacy Study of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation
A Phase 2 study testing ramosetron in people with Hematologic Malignancies, run by The Catholic University of Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- ramosetron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to Feb 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Catholic Blood & Marrow Transplantation Center, Seoul St Mary's Hospital, the Catholic University of Korea
Seoul, 137-701
Bo-Kyung Kim, RN, 82-50-7448-6371, mikaella7@naver.com
Ki-Seong Eom, MD, 82-2-2258-6056, dreom@catholic.ac.kr
About this study
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
- 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
- Conditions
- Hematologic Malignancies
- Being tested
- ramosetron
- Keywords
- hematologic malignancies, hematopoietic stem cell transplantation, ramosetron, emesis
- Medical subject headings
- Hematologic Neoplasms, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ramosetronDrug
| Study group | Role | What they receive |
|---|---|---|
| ramosetron | Experimental | Not described Receives: Drug: ramosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 1 week after the end of conditioning regimen
Secondary outcomes (1)
the efficacy of second dose of ramosetron for the treatment of breakthrough emesis
Measured: within 1 week after the end of conditioning regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startAug 2014
- Primary completionDec 2014
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki-Seong Eom, MD, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788605
- Sponsor's protocol ID
- CBMTC-supp001
- Status last verified
- Dec 2014
- First submitted
- 7 Feb 2013
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01788605
- Acronym / sponsor ID
- CBMTC-supp001
- Conditions
- Hematologic Malignancies
- Keywords
- hematologic malignancies, hematopoietic stem cell transplantation, ramosetron, emesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (estimated)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ramosetron | Experimental | Drug: ramosetron |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- Patients complicating
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ramosetron | Drug | ramosetron |
Primary outcome
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
1 secondary outcome
the efficacy of second dose of ramosetron for the treatment of breakthrough emesis
Time frame: within 1 week after the end of conditioning regimen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catholic Blood & Marrow Transplantation Center, Seoul St Mary's Hospital, the Catholic University of Korea
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ramosetron in people with Hematologic Malignancies, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: within 1 week after the end of conditioning regimen). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.