Palifermin for Patients Receiving Hematopoietic Stem Cell Transplantation
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
1 other identifier
interventional
88
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2015
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2014
CompletedFirst Posted
Study publicly available on registry
December 10, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedDecember 10, 2014
December 1, 2014
2 months
December 5, 2014
December 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
5 weeks
Secondary Outcomes (6)
Incidence of severe oral mucositis after stem cell transplantation
5 weeks
Average VAS score during severe oral mucositis
5 weeks
Requirement of opioid drugs during severe oral mucositis
5 weeks
Requirement of opioid drugs
5 weeks
Cost effectiveness of palifermin during stem cell transplantation
5 weeks
- +1 more secondary outcomes
Study Arms (2)
Palifermin
ACTIVE COMPARATORThe 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 COMPARATORThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- adequate organ function
- patients who will receive autologous stem cell transplantation
- patients who will receive allogeneic stem cell transplantation using myeloablative conditioning regimen
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Catholic University of Korealead
- BLNHcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 5, 2014
First Posted
December 10, 2014
Study Start
January 1, 2015
Primary Completion
March 1, 2015
Study Completion
June 1, 2015
Last Updated
December 10, 2014
Record last verified: 2014-12