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

Not Recruiting

Trial ID: NCT00189488

Purpose

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.

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

Stanford Investigator(s)

Laura Johnston
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Negrin
Robert Negrin

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Sally Arai
Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Judith Shizuru
Judith Shizuru

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)

Eligibility


Inclusion Criteria:

   - Subjects with hematologic malignancies (including myelodysplastic syndromes [MDS]) who
   are considered eligible for Cyclophosphamide (Cy)/Total Body Irradiation(TBI) +/-
   Etoposide (VP-16); Total Body Irradiation(TBI)/ Etoposide(VP-16); Melphalan(Mel) /
   Total Body Irradiation(TBI); Busulfan(Bu)/ Cyclophosphamide(Cy); Busulfan(Bu)/
   Melphalan (Mel); or Fludarabine(Flu)/ Melphalan(Mel) conditioning therapy with
   allogeneic stem cell support

   - Subjects with a 6/6 Human Leukocyte Antigen (HLA)-matched family member or unrelated
   donor who would provide donor marrow/ peripheral progenitor stem cells. [For unrelated
   matched donors, molecular typing of class I and class II is mandatory]

   - Karnofsky Performance Status >= 70%

   - 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:

   - Cancer other than Non-Hodgkin's lymphoma, Hodgkin's disease, acute myelogenous
   leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic
   lymphocytic leukemia, myelodysplastic syndrome or multiple myeloma (except: adequately
   treated basal cell carcinoma of the skin)

   - Prior autologous or allogeneic bone marrow or peripheral blood stem cell
   transplantation

   - Previous use of palifermin

   - Current active infection (including human immunodeficiency virus (HIV) and hepatitis)
   or oral mucositis

   - Congestive heart failure as defined by New York Heart Association class III or IV

   - Graft T-cell depletion for Graft-versus-host disease (GVHD) prophylaxis

   - Inadequate renal function (serum creatinine > 1.5x the upper limit of normal per the
   institutional guidelines or clearance < 40 ml/min adjusted for age)

   - Inadequate liver function (total bilirubin > 1.5x the upper limit of normal, aspartate
   aminotransferase (AST) > 3x upper limit of normal and/or alanine aminotransferase
   (ALT) > 3x upper limit of normal per the institutional guidelines)

   - Inadequate pulmonary function as measured by a corrected DLCO (diffusing capacity of
   the lung for carbon monoxide lung function test) <50% of predicted

   - Subject is currently enrolled in or has not yet completed at least 30 days since
   ending other investigational device or drug trial(s), or subject is receiving other
   investigational agent(s)

   - Subject of child-bearing potential is evidently pregnant (e.g. positive human
   chorionic gonadotropin- HCG test) or is breast feeding during Part A of the study

   - Subject or partner of subject is not using or refuses to use adequate contraceptive
   precautions during Part A of the study

   - Subject has known sensitivity to any of the products to be administered during dosing
   including Escherichia coli-derived products

   - Subject was previously randomized into this study

   - 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

Intervention(s):

drug: Palifermin

drug: Placebo

other: Conditioning Regimen

procedure: Allogeneic stem cell transplant

drug: Methotrexate

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
6507230822

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