Clinical trial NCT00189488 (phase 2, status: completed)
Conditions: graft versus host disease, hematologic malignancies
ICD codes: D89.810, D89.811, D89.813, D89.812, E70.338, E70.339, P09.3, O28.0, P61.8, P61.9, T45.8X1A
Drugs: palifermin, placebo, methotrexate
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O
Eligibility criteria:

        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