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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Swedish Orphan Biovitrum.
Recruitment status was  Active, not recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 26, 2014