Palifermin for Patients Receiving Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Mucositis

Intervention / Treatment
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* Drug: Palifermin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adequate organ function patients who will receive autologous stem cell transplantation patients who will receive allogeneic stem cell transplantation using myeloablative conditioning regimen Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Palifermin<br>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 | Drug: Palifermin<br> <br> |
| Placebo Comparator: Normal saline<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 5 weeks | 
| Requirement of opioid drugs | from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation | 5 weeks | 
| Cost effectiveness of palifermin during stem cell transplantation | from admission for stem cell transplantation to discharge | 5 weeks | 
| Quality of life during transplant period | 1 week before stem cell infusion to discharge | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematopoietic stem cell transplantation, Palifermin