Palifermin for Patients Receiving Hematopoietic Stem Cell Transplantation

Phase 3

• Conditions: Mucositis
• Interventions: Drug: Palifermin

• Registration Number: NCT02313792
• Lead Sponsor: The Catholic University of Korea

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2014-12
• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-08
• Last Update Submitted: 2014-12-08
• Study First Posted: 2014-12-10
• Last Update Posted: 2014-12-10
• Study Start: 2015-01
• Primary Completion: 2015-03
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Palifermin	Palifermin	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

Primary Outcome Measures

Name	Time	Method
Duration of severe oral mucositis after stem cell transplantation	5 weeks	from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation

Secondary Outcome Measures

Name	Time	Method
Requirement of opioid drugs	5 weeks	from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation
Quality of life during transplant period	5 weeks	1 week before stem cell infusion to discharge
Average VAS score during severe oral mucositis	5 weeks	from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation
Cost effectiveness of palifermin during stem cell transplantation	5 weeks	from admission for stem cell transplantation to discharge
Incidence of severe oral mucositis after stem cell transplantation	5 weeks	from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation
Requirement of opioid drugs during severe oral mucositis	5 weeks	from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation