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Palifermin for Patients Receiving Hematopoietic Stem Cell Transplantation

NCT ID: NCT02313792

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Mucositis

Keywords

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Hematopoietic stem cell transplantation Palifermin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Palifermin

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Palifermin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BLNH

UNKNOWN

Sponsor Role collaborator

The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Ki-Seong Eom, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CBMTC-supp002

Identifier Type: -

Identifier Source: org_study_id