Non Hodgkin Lymphoma Clinical Trial
Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
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
Full 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.
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
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There is 1 Location for this study
Seattle Washington, 98109, United States
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