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Phase 2 N=155 Randomized Double-blind Treatment

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

Graft Versus Host Disease · Hematologic Malignancies

Bottom Line

View on ClinicalTrials.gov: NCT00189488 ↗
Enrolled (actual)
155
Serious AEs
59.6%
Results posted
Sep 2014
Primary outcome: Primary: Number of Participants With Severe (Grade 3 and 4) Acute Graft Versus Host Disease (GVHD) — 12; 12; 60; 62 Participants — p=0.929

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Palifermin (Drug); Placebo (Drug); Conditioning Regimen (Other); Allogeneic stem cell transplant (Procedure); Methotrexate (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Swedish Orphan Biovitrum
Primary completion
Nov 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Severe (Grade 3 and 4) Acute Graft Versus Host Disease (GVHD)		 12; 12; 60; 62 0.929
SECONDARY
Number of Participants With Grade 2 to 4 Acute Graft Versus Host Disease (GVHD)		 29; 43; 43; 31 0.034 sig
SECONDARY
Number of Participants With Day 11 Methotrexate Graft Versus Host Disease Prophylaxis Administration		 56; 60; 22; 17 0.352
SECONDARY
Number of Participants With Severe (Grade 3 or 4) Oral Mucositis		 57; 62; 16; 13; 5; 2 0.675
SECONDARY
Duration of Severe Oral Mucositis (WHO Grade 3 and 4)		 8.1; 7.8 0.953
SECONDARY
Number of Participants With Parenteral or Transdermal Opioid Analgesic Use		 50; 48; 28; 29 0.797
SECONDARY
Duration of Hospitalization		 36.1; 42.2 0.186
SECONDARY
Area Under the Curve (AUC) of Mouth and Throat Soreness Score		 43.0; 47.7 0.219

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00189488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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