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Palifermin for Patients Receiving Hematopoietic Stem Cell Transplantation

Primary Purpose

Mucositis

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Palifermin
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mucositis focused on measuring Hematopoietic stem cell transplantation, Palifermin

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Palifermin

    Normal saline

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    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
    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
    Requirement of opioid drugs
    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
    from admission for stem cell transplantation to discharge
    Quality of life during transplant period
    1 week before stem cell infusion to discharge

    Full Information

    First Posted
    December 5, 2014
    Last Updated
    December 8, 2014
    Sponsor
    The Catholic University of Korea
    Collaborators
    BLNH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02313792
    Brief Title
    Palifermin for Patients Receiving Hematopoietic Stem Cell Transplantation
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    March 2015 (Anticipated)
    Study Completion Date
    June 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Catholic University of Korea
    Collaborators
    BLNH

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mucositis
    Keywords
    Hematopoietic stem cell transplantation, Palifermin

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    88 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Palifermin
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Normal saline
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Palifermin
    Primary Outcome Measure Information:
    Title
    Duration of severe oral mucositis after stem cell transplantation
    Description
    from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation
    Time Frame
    5 weeks
    Secondary Outcome Measure Information:
    Title
    Incidence of severe oral mucositis after stem cell transplantation
    Description
    from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation
    Time Frame
    5 weeks
    Title
    Average VAS score during severe oral mucositis
    Description
    from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation
    Time Frame
    5 weeks
    Title
    Requirement of opioid drugs during severe oral mucositis
    Description
    from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation
    Time Frame
    5 weeks
    Title
    Requirement of opioid drugs
    Description
    from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation
    Time Frame
    5 weeks
    Title
    Cost effectiveness of palifermin during stem cell transplantation
    Description
    from admission for stem cell transplantation to discharge
    Time Frame
    5 weeks
    Title
    Quality of life during transplant period
    Description
    1 week before stem cell infusion to discharge
    Time Frame
    5 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Palifermin for Patients Receiving Hematopoietic Stem Cell Transplantation

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