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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Graft Versus Host Disease, Hematologic Malignancies

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Graft Vs Host Disease (GVHD)

Outcome Time Frame:

Dec 2008

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Biovitrum AB

Authority:

United States: Food and Drug Administration

Study ID:

20040213

NCT ID:

NCT00189488

Start Date:

August 2005

Completion Date:

December 2013

Related Keywords:

  • Graft Versus Host Disease
  • Hematologic Malignancies
  • Hematological Malignancies
  • Graft-versus-host-disease
  • Oral Mucositis
  • Allogeneic Transplantation
  • Neoplasms
  • Graft vs Host Disease
  • Hematologic Neoplasms

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