Clinical trial · Interventional

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

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

NCT00189488CI-TRIAL-00015609completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Graft Versus Host Disease	—	UNRESOLVED	—
Hematologic Malignancies	Hematopoietic and Lymphoid Cell Neoplasm	ALIAS	0.90

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
Allogeneic stem cell transplant	Procedure	—	UNRESOLVED
Conditioning Regimen	Other	—	UNRESOLVED
Methotrexate	Drug	Methotrexate	ALIAS
Palifermin	Drug	—	UNRESOLVED
Placebo	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Palifermin
description
Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg. Participants received conditioning therapy starting at least 24 hours after the last 60 μg dose of palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the 180 μg/kg dose of palifermin on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m\^2 respectively.
interventionNames
1. Drug: Palifermin
2. Other: Conditioning Regimen
3. Procedure: Allogeneic stem cell transplant
4. Drug: Methotrexate
type
PLACEBO_COMPARATOR
label
Placebo
description
Placebo to palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to palifermin 180 μg/kg once prior to transplant and at least 96 hours from previous placebo to palifermin 60 μg/kg dose. Participants received conditioning therapy starting at least 24 hours after the last 60 μg/kg dose of placebo to palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the dose of placebo to palifermin 180 μg/kg on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m\^2 respectively.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.