The purpose of this research is to test the safety and efficacy of brentuximab vedotin in patients with acute skin graft-versus-host disease (GVHD)
PRIMARY OBJECTIVES: I. Determine whether the complete and partial response rate of steroid-resistant skin GVHD exceeds 25% after administration of brentuximab vedotin. SECONDARY OBJECTIVES: I. Evaluate the effect of brentuximab vedotin on the clinical manifestations of acute GVHD of the liver and gastrointestinal tract. II. Determine the incidence and degree of brentuximab vedotin-related toxicity when administered after allogeneic hematopoietic cell transplantation (HCT). III. Evaluate cluster of differentiation (CD)30 expression in skin biopsies before and after administration of brentuximab vedotin. IV. Enumerate CD30 expressing lymphocytes in the blood and measure the concentration of soluble CD30 in serum before and after administration of brentuximab vedotin. V. Determine whether changes in CD30 expression in skin biopsies or blood lymphocytes or the concentration of CD30 in serum before and after administration of brentuximab vedotin are correlated with changes in skin GVHD stage. VI. Evaluate pharmacokinetics (PK) of brentuximab vedotin in patients after allogeneic HCT. OUTLINE: This is a dose escalation study. Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on days 1, 8, and 15. After completion of study treatment, patients are followed up for 30 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Given IV
Correlative studies
Correlative studies
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Partial and complete response rates of steroid-resistant acute skin GVHD following administration of brentuximab vedotin
Time frame: Up to day 28
Complete and partial response rates of gut and liver acute GVHD after administration of brentuximab vedotin
Time frame: Up to day 28
Incidence and severity of brentuximab vedotin-related toxicity after allogeneic HCT defined graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 4
Time frame: Assessed up to day 45
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