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

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ClinicalTrials.gov Identifier: NCT01233921
Recruitment Status : Completed
First Posted : November 3, 2010
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Martin, Paul, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
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)
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Blastic Phase Chronic Myelogenous Leukemia
Chronic Eosinophilic Leukemia
Chronic Myelomonocytic Leukemia
Chronic Neutrophilic Leukemia
Chronic Phase Chronic Myelogenous Leukemia
de Novo Myelodysplastic Syndromes
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Graft Versus Host Disease
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Nodal Marginal Zone B-cell Lymphoma
Noncontiguous Stage II Adult Burkitt Lymphoma
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 Biological: palifermin
Other: flow cytometry
Other: laboratory biomarker analysis
Other: pharmacological study
Enrollment 6
Recruitment Details Subjects were enrolled between Nov 2010 and June 2012 during outpatient follow-up after allogeneic hematopoietic cell tranpslantation.
Pre-assignment Details  
Arm/Group Title Arm I (Palifermin) Arm II (no Palifermin)
Hide Arm/Group Description Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity. Patients do not receive palifermin.
Period Title: Overall Study
Started 3 3
Completed 3 3
Not Completed 0 0
Arm/Group Title Arm I (Palifermin) Arm II (no Palifermin) Total
Hide Arm/Group Description Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity. Patients do not receive palifermin. Total of all reporting groups
Overall Number of Baseline Participants 3 3 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
3
 100.0%
6
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 6 participants
44  (13) 41  (11) 43  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Female
1
  33.3%
0
   0.0%
1
  16.7%
Male
2
  66.7%
3
 100.0%
5
  83.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 6 participants
3 3 6
1.Primary Outcome
Title Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood
Hide 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.
Time Frame Baseline and 4 weeks after administration of palifermin
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Palifermin) Arm II (no Palifermin)
Hide Arm/Group Description:
Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
Patients do not receive palifermin.
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: cells per microliter of blood
-2  (3) -22  (51)
2.Secondary Outcome
Title Changes in the Number of Naive CD4 T Cells in the Blood
Hide 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.
Time Frame Baseline and 4 weeks after administration of palifermin
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Palifermin) Arm II (no Palifermin)
Hide Arm/Group Description:
Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
Patients do not receive palifermin.
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: cells per microliter of blood
-3  (4) -25  (58)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Palifermin) Arm II (no Palifermin)
Hide Arm/Group Description Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity. Patients do not receive palifermin.
All-Cause Mortality
Arm I (Palifermin) Arm II (no Palifermin)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Palifermin) Arm II (no Palifermin)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Palifermin) Arm II (no Palifermin)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   2/3 (66.67%) 
Gastrointestinal disorders     
oral mucosal change  [1]  3/3 (100.00%)  0/3 (0.00%) 
anorexia   2/3 (66.67%)  0/3 (0.00%) 
nausea   2/3 (66.67%)  0/3 (0.00%) 
vomiting   1/3 (33.33%)  0/3 (0.00%) 
diarrhea   3/3 (100.00%)  1/3 (33.33%) 
General disorders     
edema   1/3 (33.33%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders     
pain   2/3 (66.67%)  1/3 (33.33%) 
arthralgia   2/3 (66.67%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders     
rash   2/3 (66.67%)  1/3 (33.33%) 
pruritis   0/3 (0.00%)  1/3 (33.33%) 
Indicates events were collected by systematic assessment
[1]
Hyperkeratosis and taste changes
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Paul J. Martin
Organization: Fred Hutchinson Cancer Research Cetner
Phone: 206-667-4798
Responsible Party: Martin, Paul, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
ClinicalTrials.gov Identifier: NCT01233921     History of Changes
Other Study ID Numbers: 2437.00
NCI-2010-01711 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: November 2, 2010
First Posted: November 3, 2010
Results First Submitted: December 20, 2013
Results First Posted: April 2, 2014
Last Update Posted: April 2, 2014