Palifermin for Patients Receiving Hematopoietic Stem Cell Transplantation

December 8, 2014 updated by: Ki-Seong Eom, MD, The Catholic University of Korea

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Collaborators

BLNH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

December 8, 2014

First Posted (Estimate)

December 10, 2014

Study Record Updates

Last Update Posted (Estimate)

December 10, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBMTC-supp002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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