Graft Versus Host Disease Clinical Trial
Official title:
Phase II Study to Evaluate the Efficacy of Brentuximab Vedotin in Patients With Steroid-Resistant Acute GVHD
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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