MucositisPhase 3NCT02313792
Palifermin for Patients Receiving Hematopoietic Stem Cell Transplantation
A Phase 3 study testing Palifermin in people with Mucositis, run by The Catholic University of Korea.
Trial summary
The purpose of this study is to compare the efficacy and safety of palifermin on reducing mucositis for patients receiving autologous or allogeneic stem cell transplantation with supportive care. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Mucositis
- What is being tested?
- Palifermin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2015
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adequate organ function
- patients who will receive autologous stem cell transplantation
- patients who will receive allogeneic stem cell transplantation using myeloablative conditioning regimen
Who cannot join
- presence of concomitant malignancy
- presence of active infection or oral mucositis prior to stem cell transplantation
- any conditions where the severity of oral mucositis cannot be evaluated
About this study
Official title: Efficacy, Safety and Quality of Life of Palifermin on Reducing Oral Mucositis in Patients With Hematopoietic Stem Cell Transplantation, Prospective Double-blind Randomized Phase III Trial
The purpose of this study is to compare the efficacy and safety of palifermin on reducing mucositis for patients receiving autologous or allogeneic stem cell transplantation with supportive care.
- Conditions
- Mucositis
- Being tested
- Palifermin
- Keywords
- Hematopoietic stem cell transplantation, Palifermin
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaliferminDrug
| Study group | Role | What they receive |
|---|---|---|
| Palifermin | Active comparator | The patients belong to this arm will be given palifermin, keratinocyte growth factor, in addition to the conventional supportive care for oral mucositis. Palifermin will be given at a dose of 60 mcg/kg for 3 days before commencement of the preparative regimen and for 3 days after stem cell infusion Receives: Drug: Palifermin |
| Normal saline | Placebo comparator | The patients belong to this arm will be given normal saline as placebo plus conventional supportive care for oral mucositis. Normal saline will be given at the same volume and schedule with the study drug. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of severe oral mucositis after stem cell transplantation
from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation
Measured: 5 weeks
Secondary outcomes (6)
Incidence of severe oral mucositis after stem cell transplantation
from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation
Measured: 5 weeks
Average VAS score during severe oral mucositis
from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation
Measured: 5 weeks
Requirement of opioid drugs during severe oral mucositis
from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation
Measured: 5 weeks
Requirement of opioid drugs
from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation
Measured: 5 weeks
Cost effectiveness of palifermin during stem cell transplantation
from admission for stem cell transplantation to discharge
Measured: 5 weeks
Quality of life during transplant period
1 week before stem cell infusion to discharge
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionMar 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucositisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- BLNH
- Responsible party
- Principal investigator, Ki-Seong Eom, MD, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313792
- Sponsor's protocol ID
- CBMTC-supp002
- Status last verified
- Dec 2014
- First submitted
- 5 Dec 2014
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Quality of Life of Palifermin on Reducing Oral Mucositis in Patients With Hematopoietic Stem Cell Transplantation, Prospective Double-blind Randomized Phase III Trial
- ClinicalTrials.gov ID
- NCT02313792
- Acronym / sponsor ID
- CBMTC-supp002
- Conditions
- Mucositis
- Keywords
- Hematopoietic stem cell transplantation, Palifermin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- BLNH
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 10 Dec 2014 (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 compare the efficacy and safety of palifermin on reducing mucositis for patients receiving autologous or allogeneic stem cell transplantation with supportive care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palifermin | Active comparator | Drug: PaliferminThe patients belong to this arm will be given palifermin, keratinocyte growth factor, in addition to the conventional supportive care for oral mucositis. Palifermin will be given at a dose of 60 mcg/kg for 3 days before commencement of the preparative regimen and for 3 days after stem cell infusion |
| Normal saline | Placebo comparator | –The patients belong to this arm will be given normal saline as placebo plus conventional supportive care for oral mucositis. Normal saline will be given at the same volume and schedule with the study drug. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- adequate organ function
- patients who will receive autologous stem cell transplantation
- patients who will receive allogeneic stem cell transplantation using myeloablative conditioning regimen
Key exclusion criteria (3 listed)
- presence of concomitant malignancy
- presence of active infection or oral mucositis prior to stem cell transplantation
- any conditions where the severity of oral mucositis cannot be evaluated
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 |
|---|---|---|
| Palifermin | Drug | Palifermin |
Primary outcome
Duration of severe oral mucositis after stem cell transplantation
Time frame: 5 weeks
from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation
6 secondary outcomes
Incidence of severe oral mucositis after stem cell transplantation
Time frame: 5 weeks
Average VAS score during severe oral mucositis
Time frame: 5 weeks
Requirement of opioid drugs during severe oral mucositis
Time frame: 5 weeks
Requirement of opioid drugs
Time frame: 5 weeks
Cost effectiveness of palifermin during stem cell transplantation
Time frame: 5 weeks
Quality of life during transplant period
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Palifermin in people with Mucositis, run by The Catholic University of 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 3 inclusion and 3 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 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of severe oral mucositis after stem cell transplantation (time frame: 5 weeks). 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 10 Dec 2014.