|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00189488 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Factorial Assignment, Safety/Efficacy Study |
| 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 |
| 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 |
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 More Information
| Responsible Party: | Amgen Inc. ( Global Development Leader ) |
| Study ID Numbers: | 20040213 |
| Study First Received: | September 15, 2005 |
| Last Updated: | October 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00189488 |
| Health Authority: | United States: Food and Drug Administration |
|
Hematological Malignancies Graft-versus-host-disease Oral Mucositis Allogeneic Transplantation |
|
Hematologic Neoplasms Mucositis Graft versus host disease |
Hematologic Diseases Graft vs Host Disease Homologous wasting disease |
|
Neoplasms Neoplasms by Site Immune System Diseases |
