Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma
Noncontiguous Stage II Adult Lymphoblastic Lymphoma
Noncontiguous Stage II Grade 1 Follicular Lymphoma
Noncontiguous Stage II Grade 2 Follicular Lymphoma
Noncontiguous Stage II Grade 3 Follicular Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma
Noncontiguous Stage II Marginal Zone Lymphoma
Noncontiguous Stage II Small Lymphocytic Lymphoma
Previously Treated Myelodysplastic Syndromes
Primary Myelofibrosis
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Hairy Cell Leukemia
Refractory Multiple Myeloma
Relapsing Chronic Myelogenous Leukemia
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Splenic Marginal Zone Lymphoma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Adult Burkitt Lymphoma
Stage III Adult Diffuse Large Cell Lymphoma
Stage III Adult Diffuse Mixed Cell Lymphoma
Stage III Adult Diffuse Small Cleaved Cell Lymphoma
Stage III Adult Hodgkin Lymphoma
Stage III Adult Immunoblastic Large Cell Lymphoma
Stage III Adult Lymphoblastic Lymphoma
Stage III Chronic Lymphocytic Leukemia
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Stage III Grade 3 Follicular Lymphoma
Stage III Mantle Cell Lymphoma
Stage III Marginal Zone Lymphoma
Stage III Multiple Myeloma
Stage III Small Lymphocytic Lymphoma
Stage IV Adult Burkitt Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Stage IV Adult Diffuse Mixed Cell Lymphoma
Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
Stage IV Adult Hodgkin Lymphoma
Stage IV Adult Immunoblastic Large Cell Lymphoma
Stage IV Adult Lymphoblastic Lymphoma
Stage IV Chronic Lymphocytic Leukemia
Stage IV Grade 1 Follicular Lymphoma
Stage IV Grade 2 Follicular Lymphoma
Stage IV Grade 3 Follicular Lymphoma
Stage IV Mantle Cell Lymphoma
Stage IV Marginal Zone Lymphoma
Stage IV Small Lymphocytic Lymphoma
Interventions
palifermin
flow cytometry
laboratory biomarker analysis
pharmacological study
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01233921
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2437.00
Secondary IDs
ID
Type
Description
Link
NCI-2010-01711
Registry Identifier
CTRP (Clinical Trial Reporting Program)
Brief Title
Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
Official Title
A Preliminary Study to Evaluate the Effects of Palifermin in Patients at Risk of Chronic Graft-versus-host Disease
Acronym
Not provided
Organization
Fred Hutchinson Cancer CenterOTHER
Status Module
Record Verification Date
Feb 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2010
Primary Completion Date
Jul 2012Actual
Completion Date
Not provided
First Submitted Date
Nov 2, 2010
First Submission Date that Met QC Criteria
Nov 2, 2010
First Posted Date
Nov 3, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 20, 2013
Results First Submitted that Met QC Criteria
Feb 19, 2014
Results First Posted Date
Apr 2, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 19, 2014
Last Update Posted Date
Apr 2, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Martin, Paul, Member, Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSponsor-Investigator
Lead Sponsor
Martin, PaulOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma
Noncontiguous Stage II Adult Lymphoblastic Lymphoma
Noncontiguous Stage II Grade 1 Follicular Lymphoma
Noncontiguous Stage II Grade 2 Follicular Lymphoma
Noncontiguous Stage II Grade 3 Follicular Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma
Noncontiguous Stage II Marginal Zone Lymphoma
Noncontiguous Stage II Small Lymphocytic Lymphoma
Previously Treated Myelodysplastic Syndromes
Primary Myelofibrosis
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
6Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm I (palifermin)
Experimental
Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
Biological: palifermin
Other: flow cytometry
Other: laboratory biomarker analysis
Other: pharmacological study
Arm II (no palifermin)
Active Comparator
Patients do not receive palifermin.
Other: flow cytometry
Other: laboratory biomarker analysis
Other: pharmacological study
Interventions
Name
Type
Description
Arm Group Labels
Other Names
palifermin
Biological
Given IV
Arm I (palifermin)
growth factor, recombinant human keratinocyte
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood
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.
Baseline and 4 weeks after administration of palifermin
Secondary Outcomes
Measure
Description
Time Frame
Changes in the Number of Naive CD4 T Cells in the Blood
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.
Baseline and 4 weeks after administration of palifermin
Other Outcomes
Not provided
Eligibility Module
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Paul Martin
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle
Washington
98109
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Subjects were enrolled between Nov 2010 and June 2012 during outpatient follow-up after allogeneic hematopoietic cell tranpslantation.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm I (Palifermin)
Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
FG001
Arm II (no Palifermin)
Patients do not receive palifermin.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Refractory Hairy Cell Leukemia
Refractory Multiple Myeloma
Relapsing Chronic Myelogenous Leukemia
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Splenic Marginal Zone Lymphoma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Adult Burkitt Lymphoma
Stage III Adult Diffuse Large Cell Lymphoma
Stage III Adult Diffuse Mixed Cell Lymphoma
Stage III Adult Diffuse Small Cleaved Cell Lymphoma
Stage III Adult Hodgkin Lymphoma
Stage III Adult Immunoblastic Large Cell Lymphoma
Stage III Adult Lymphoblastic Lymphoma
Stage III Chronic Lymphocytic Leukemia
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Stage III Grade 3 Follicular Lymphoma
Stage III Mantle Cell Lymphoma
Stage III Marginal Zone Lymphoma
Stage III Multiple Myeloma
Stage III Small Lymphocytic Lymphoma
Stage IV Adult Burkitt Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Stage IV Adult Diffuse Mixed Cell Lymphoma
Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
Stage IV Adult Hodgkin Lymphoma
Stage IV Adult Immunoblastic Large Cell Lymphoma
Stage IV Adult Lymphoblastic Lymphoma
Stage IV Chronic Lymphocytic Leukemia
Stage IV Grade 1 Follicular Lymphoma
Stage IV Grade 2 Follicular Lymphoma
Stage IV Grade 3 Follicular Lymphoma
Stage IV Mantle Cell Lymphoma
Stage IV Marginal Zone Lymphoma
Stage IV Small Lymphocytic Lymphoma
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Supportive Care
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Kepivance
keratinocyte growth factor, recombinant human
recombinant human keratinocyte growth factor
rhKGF
flow cytometry
Other
Correlative studies
Arm I (palifermin)
Arm II (no palifermin)
laboratory biomarker analysis
Other
Correlative studies
Arm I (palifermin)
Arm II (no palifermin)
pharmacological study
Other
Correlative studies
Arm I (palifermin)
Arm II (no palifermin)
pharmacological studies
FG0003 subjects
FG0013 subjects
COMPLETED
FG0003 subjects
FG0013 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm I (Palifermin)
Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
BG001
Arm II (no Palifermin)
Patients do not receive palifermin.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0026
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
Between 18 and 65 years
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00044± 13
BG00141± 11
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood
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.
Posted
Mean
Standard Deviation
cells per microliter of blood
Baseline and 4 weeks after administration of palifermin
ID
Title
Description
OG000
Arm I (Palifermin)
Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
OG001
Arm II (no Palifermin)
Patients do not receive palifermin.
Units
Counts
Participants
OG0003
OG0013
Title
Denominators
Categories
Title
Measurements
OG000-2± 3
OG001-22± 51
Secondary
Changes in the Number of Naive CD4 T Cells in the Blood
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.
Posted
Mean
Standard Deviation
cells per microliter of blood
Baseline and 4 weeks after administration of palifermin
ID
Title
Description
OG000
Arm I (Palifermin)
Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
OG001
Arm II (no Palifermin)
Patients do not receive palifermin.
Units
Counts
Participants
OG000
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Arm I (Palifermin)
Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.