Status:
COMPLETED
Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
Lead Sponsor:
Martin, Paul
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Eligibility:
All Genders
18+ years
Phase:
NA
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 preven...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01233921
Start Date
September 1 2010
Last Update
April 2 2014
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109