Palifermin for Patients Receiving Hematopoietic Stem Cell Transplantation

Mucositis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02313792
• Other study ID #: CBMTC-supp002
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 5, 2014
• Last updated: December 8, 2014
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: December 2014
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mucositis

Intervention

Drug:
• Palifermin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Catholic University of Korea	BLNH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Requirement of opioid drugs	from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation	5 weeks	Yes
Secondary	Cost effectiveness of palifermin during stem cell transplantation	from admission for stem cell transplantation to discharge	5 weeks	No
Secondary	Quality of life during transplant period	1 week before stem cell infusion to discharge	5 weeks	No