Palifermin for Patients Receiving Hematopoietic Stem Cell Transplantation

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02313792

Enrollment

Registered

2014-12-10

Start date

2015-01-31

Completion date

2015-06-30

Last updated

2014-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucositis

Keywords

Hematopoietic stem cell transplantation, Palifermin

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.

Interventions

DRUGPalifermin

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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
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
Requirement of opioid drugs	5 weeks	from onset of severe oral mucositis till resolution of the mucositis or 28 days after stem cell transplantation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026