NCT00189488

Trial to Evaluate Palifermin in the Reduction of Acute Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Allogeneic Marrow/Peripheral Blood Progenitor Cell (PBPC) Transplantation

A Randomized, Double-blind, Placebo-controlled Trial to Evaluate Palifermin (rHuKGF) in the Reduction of Acute Graft Versus Host Disease in Subjects With Hematologic Malignancies Undergoing Allogeneic Marrow/PBPC Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Swedish Orphan Biovitrum · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the effect of palifermin versus placebo in the reduction of severe acute graft versus host disease (GVHD) and severe oral mucositis.

Conditions

• Graft Versus Host Disease
• Hematologic Malignancies

Interventions

Type	Name	Description
DRUG	Palifermin	Administered as an intravenous (IV) bolus.
DRUG	Placebo	Administered as an intravenous (IV) bolus.
OTHER	Conditioning Regimen	Each participant received 1 of the following conditioning regimens: * Cyclophosphamide (Cy) / total body irradiation (TBI) with and without etoposide (VP-16) * TBI/VP-16 * Melphalan (Mel)/TBI (TBI regimens must include fully ablative doses ie \> 1100 cGy; sequence of chemotherapy/radiation (CT/RT) flexible) * Busulfan (Bu)/Cy * Bu/Mel (non-TBI but fully ablative regimens/doses \[Mel dose \> 140 mg/m\^2\]) * Fludarabine (Flu)/Mel (non-TBI but fully ablative regimens/doses \[Mel dose \> 140 mg/m\^2\])
PROCEDURE	Allogeneic stem cell transplant	Allogeneic marrow/peripheral blood progenitor cell transplantation
DRUG	Methotrexate

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-11-01
• Completion: 2013-08-01
• First posted: 2005-09-19
• Last updated: 2014-09-15
• Results posted: 2014-09-15