Palifermin for Patients Receiving Hematopoietic Stem Cell Transplantation

Sponsor

The Catholic University of Korea (Other)

Overall Status

Unknown status

CT.gov ID

NCT02313792

Collaborator

BLNH (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mucositis	Drug: Palifermin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Study Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

Mar 1, 2015

Anticipated Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: Palifermin
Placebo Comparator: Normal saline 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.

Arm

Intervention/Treatment

Active Comparator: 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

Drug: Palifermin

Placebo Comparator: Normal saline

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.

Outcome Measures

Primary Outcome Measures

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

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
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
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
Requirement of opioid drugs [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
Quality of life during transplant period [5 weeks]
1 week before stem cell infusion to discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The Catholic University of Korea
BLNH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ki-Seong Eom, MD, Associate Professor, The Catholic University of Korea

ClinicalTrials.gov Identifier:

NCT02313792

Other Study ID Numbers:

CBMTC-supp002

First Posted:

Dec 10, 2014

Last Update Posted:

Dec 10, 2014

Last Verified:

Dec 1, 2014

Keywords provided by Ki-Seong Eom, MD, Associate Professor, The Catholic University of Korea

Hematopoietic stem cell transplantation

Palifermin

Additional relevant MeSH terms:

Mucositis

Study Results

No Results Posted as of Dec 10, 2014