Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
A Preliminary Study to Evaluate the Effects of Palifermin in Patients at Risk of Chronic Graft-versus-host Disease
2 other identifiers
interventional
6
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 2, 2010
CompletedFirst Posted
Study publicly available on registry
November 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedResults Posted
Study results publicly available
April 2, 2014
CompletedApril 2, 2014
February 1, 2014
1.8 years
November 2, 2010
December 20, 2013
February 19, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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 (1)
Changes in the Number of Naive CD4 T Cells in the Blood
Baseline and 4 weeks after administration of palifermin
Study Arms (2)
Arm I (palifermin)
EXPERIMENTALPatients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
Arm II (no palifermin)
ACTIVE COMPARATORPatients do not receive palifermin.
Interventions
Given IV
Correlative studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Martin, Paullead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Paul J. Martin
- Organization
- Fred Hutchinson Cancer Research Cetner
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Martin
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Member
Study Record Dates
First Submitted
November 2, 2010
First Posted
November 3, 2010
Study Start
September 1, 2010
Primary Completion
July 1, 2012
Last Updated
April 2, 2014
Results First Posted
April 2, 2014
Record last verified: 2014-02