Brentuximab Vedotin in Treating Patients With Steroid-Resistant Acute Graft-Versus-Host Disease
Graft Versus Host Disease
Drug: brentuximab vedotin
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Phase II Study to Evaluate the Efficacy of Brentuximab Vedotin in Patients With Steroid-Resistant Acute GVHD|
- Partial and complete response rates of steroid-resistant acute skin GVHD following administration of brentuximab vedotin [ Time Frame: Up to day 28 ] [ Designated as safety issue: No ]
- Complete and partial response rates of gut and liver acute GVHD after administration of brentuximab vedotin [ Time Frame: Up to day 28 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2012|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Supportive care (brentuximab vedotin)
Patients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15.
Drug: brentuximab vedotin
Other Names:Other: laboratory biomarker analysis
Correlative studiesOther: pharmacological study
Other Name: pharmacological studies
I. Determine whether the complete and partial response rate of steroid-resistant skin GVHD exceeds 25% after administration of brentuximab vedotin.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616680
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Merav Bar||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|