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

Phase 2 Completed 155 enrolled Swedish Orphan Biovitrum Amgen · collab

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2005-12
Primary completion: 2008-11
Completion: 2013-08

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Palifermin	Protein / enzyme biologic	60 ug/kg	Intravenous
Background	Methotrexate	Small molecule	10 mg/m2	—

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

Summary

Timeline

Drugs

Indications