NCT01616680

Brentuximab Vedotin in Treating Patients With Steroid-Resistant Acute Graft-Versus-Host Disease

Phase II Study to Evaluate the Efficacy of Brentuximab Vedotin in Patients With Steroid-Resistant Acute GVHD

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	brentuximab vedotin	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-06-01
• First posted: 2012-06-12
• Last updated: 2013-06-27

Locations

1 site across 1 country: United States