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NCT01233921 · REGISTRY CONDITION SEARCH

Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2014-04-02

RATIONALE: Growth factors, such as palifermin, may prevent chronic graft-versus-host disease caused by donor stem cell transplant. PURPOSE: This randomized clinical trial studies palifermin in preventing chronic graft-versus-host disease in patients who have undergone donor stem cell transplant for hematologic cancer

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood

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outcome · POSTED

Changes in the Number of Naive CD4 T Cells in the Blood

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Survival for more than 60 days after an allogeneic hematopoietic cell transplantation (HCT) with growth-factor mobilized blood cells * Current dose of prednisone at =\< 0.5 mg/kg or equivalent or no systemic glucocorticoid treatment * Ability to remain under care at the Seattle Cancer Care Alliance (SCCA) for at least 28 days after enrollment in the study * Able and willing to give informed consent Exclusion Criteria: * Presence of generalized rash involving more than 50% of the body surface * Prior diagnosis of chronic GVHD requiring systemic immunosuppressive treatment * Any prior local irradiation to a field that included the thymus (total body irradiation is allowed) * History of thymectomy * Use of rabbit antithymocyte globulin in the pretransplant conditioning regimen * Use of a graft depleted of T cells * Any evidence of recurrent or persistent malignancy after HCT * Participation in another study with chronic GVHD as the primary endpoint * Any prior history of carcinoma * Any infection that is not improving during appropriate treatment * History of palifermin intolerance * A positive pregnancy test (women of child-bearing potential) * Breast feeding
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
    intervention Names
    1. Biological: palifermin
    2. Other: flow cytometry
    3. Other: laboratory biomarker analysis
    4. Other: pharmacological study
    label
    Arm I (palifermin)
    type
    EXPERIMENTAL
  2. description
    Patients do not receive palifermin.
    intervention Names
    1. Other: flow cytometry
    2. Other: laboratory biomarker analysis
    3. Other: pharmacological study
    label
    Arm II (no palifermin)
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I (palifermin)
    description
    Given IV
    name
    palifermin
    other Names
    1. growth factor, recombinant human keratinocyte
    2. Kepivance
    3. keratinocyte growth factor, recombinant human
    4. recombinant human keratinocyte growth factor
    5. rhKGF
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Arm I (palifermin)
    2. Arm II (no palifermin)
    description
    Correlative studies
    name
    flow cytometry
    type
    OTHER
  3. arm Group Labels
    1. Arm I (palifermin)
    2. Arm II (no palifermin)
    description
    Correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
  4. arm Group Labels
    1. Arm I (palifermin)
    2. Arm II (no palifermin)
    description
    Correlative studies
    name
    pharmacological study
    other Names
    1. pharmacological studies
    type
    OTHER
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
6
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    RTE CD4 T cells will be defined according to co-expression of CD3, CD4, CD31, CD45RA, and CCR7. Cells will be counted by flow cytometry at baseline and at 4 weeks and changes will be measured as cells per microliter of blood. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.
    measure
    Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood
    time Frame
    Baseline and 4 weeks after administration of palifermin
secondary Outcomes
  1. description
    Naive CD4 T cells will be defined according to co-expression of CD3, CD4, CD45RA, and CCR7. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.
    measure
    Changes in the Number of Naive CD4 T Cells in the Blood
    time Frame
    Baseline and 4 weeks after administration of palifermin
Full study description
brief Summary
RATIONALE: Growth factors, such as palifermin, may prevent chronic graft-versus-host disease caused by donor stem cell transplant. PURPOSE: This randomized clinical trial studies palifermin in preventing chronic graft-versus-host disease in patients who have undergone donor stem cell transplant for hematologic cancer
detailed Description
OBJECTIVES: I. To evaluate the pharmacodynamic effects of palifermin on thymic function in patients at risk of chronic graft-vs-host disease (GVHD). II. To evaluate the tolerability of palifermin in patients at risk of chronic GVHD. OUTLINE: Patients are assigned to 1 of 2 groups based on whether they wish to receive palifermin or not. GROUP 1: Patients receive palifermin intravenously (IV) on days 1-3 in the absence of unacceptable toxicity. GROUP 2: Patients do not receive palifermin. After completion of study treatment, patients are followed up on days 7, 14, 21, and 28.
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice