Palifermin for Patients Receiving Hematopoietic Stem Cell Transplantation

The Catholic University of Korea

Status and phase: Unknown; Phase 3

Conditions: Mucositis

Treatments: Drug: Palifermin

Study type: Interventional

Funder types: Other

Identifiers

NCT02313792

CBMTC-supp002

Details and patient eligibility

About

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.

Enrollment: 88 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups, including a placebo group

Palifermin

Active Comparator group

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

Treatment:

Drug: Palifermin

Normal saline

Placebo Comparator group

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.