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
Condition: Graft Versus Host Disease; Hematologic Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms; Graft vs Host Disease
Intervention: Palifermin; Placebo; Conditioning Regimen; Allogeneic stem cell transplant; Methotrexate
Intervention description: Administered as an intravenous (IV) bolus.; Administered as an intravenous (IV) bolus.; Each participant received 1 of the following conditioning regimens:
Cyclophosphamide (Cy) / total body irradiation (TBI) with and without etoposide (VP-16)
TBI/VP-16
Melphalan (Mel)/TBI (TBI regimens must include fully ablative doses ie > 1100 cGy; sequence of chemotherapy/radiation (CT/RT) flexible)
Busulfan (Bu)/Cy
Bu/Mel (non-TBI but fully ablative regimens/doses [Mel dose > 140 mg/m^2])
Fludarabine (Flu)/Mel (non-TBI but fully ablative regimens/doses [Mel dose > 140 mg/m^2]); Allogeneic marrow/peripheral blood progenitor cell transplantation
Intervention MeSH terms: Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hematological Malignancies; Graft-versus-host-disease; Oral Mucositis; Allogeneic Transplantation

Summary:

      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.
    

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