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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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Amgen
Information provided by:
Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:
NCT00189488
First received: September 15, 2005
Last updated: February 27, 2009
Last verified: October 2008
History of Changes
  Purpose

The purpose of this study is to reduce the incidence of grade 2-4 GVHD and WHO grades 3-4 Oral Mucositis.


Condition Intervention Phase
Graft Versus Host Disease
Hematologic Malignancies
 Drug: Palifermin
Drug: palifermin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Palifermin
U.S. FDA Resources

Further study details as provided by Swedish Orphan Biovitrum:

Primary Outcome Measures:
  • Graft Vs Host Disease (GVHD) [ Time Frame: Dec 2008 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Oral Mucositis [ Time Frame: Dec 2008 ] [ Designated as safety issue: Yes ]

Enrollment: 155
Study Start Date: August 2005
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm B
Palifermin 50 mcg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 mcg/kg administered once at least 96 hours from last palifermin dose of 60 mcg/kg
 Drug: palifermin
Palifermin 50 mcg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 mcg/kg administered once at least 96 hours from last palifermin dose of 60 mcg/kg
Arm A
Placebo 60 mcg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 mcg/kg administered once at least 96 hours from last placebo dose of 60 mcg/kg
 Drug: Palifermin
Placebo 60 mcg/kg adminstered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 mcg/kg administered once at least 96 hours from last placebo dose of 60 mcg/kg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: - Subjects with hematologic malignancies (including myelodysplastic syndromes [MDS]) who are considered eligible for Cy/TBI +/- VP-16; TBI/VP-16; Mel/TBI; Bu/Cy; Bu/Mel; Flu/Mel conditioning - 18 years of age or older at time of informed consent - Before any study-specific procedure, the appropriate written informed consent must be obtained Exclusion Criteria: - Prior autologous or allogeneic bone marrow or peripheral blood stem cell transplantation - Previous use of palifermin - Subject will not be available for follow-up assessments - Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures - Subject of child-bearing potential is evidently pregnant (e.g., positive HCG test) or is breast feeding during Part A of the study

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189488

Sponsors and Collaborators
Swedish Orphan Biovitrum
Amgen
Investigators
Study Director: MD Biovitrum AB
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Clinical Development, Biovitrum AB (publ)
ClinicalTrials.gov Identifier: NCT00189488     History of Changes
Obsolete Identifiers: NCT00964899
Other Study ID Numbers: 20040213
Study First Received: September 15, 2005
Last Updated: February 27, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Swedish Orphan Biovitrum:
Hematological Malignancies
Graft-versus-host-disease
Oral Mucositis
Allogeneic Transplantation

Additional relevant MeSH terms:
Neoplasms
Graft vs Host Disease
Hematologic Neoplasms
 Immune System Diseases
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013