This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin to evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas.
This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin to evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas. The ORR will be evaluated based on the revised Cheson's criteria or modified SWAT criteria in case of cutaneous EBV- and CD30-positive lymphomas.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Brentuximab vedotin administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg q 3 weeks.
Seoul National University Bundang Hospital
Seongnam, South Korea
Seoul National Unversity Hospital
Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, South Korea
To Evaluate the Overall Response Rate (ORR) of Brentuximab Vedotin in EBV- and CD30-positive Lymphomas
The primary endpoint was the ORR based on the revised criteria or modified Severity Weighted Assessment Tool (SWAT) criteria in the case of cutaneous lymphomas.
Time frame: One-year
To Evaluate the Safety Profile
AEs/SAEs occurring during the study period defined by CTCAE version 4.03
Time frame: From the first dose of brentuximab vedotin to up to 30 days after the last dose, a total of up to approximately 366 days
To Calculate Progression-free Survival (PFS) Time
PFS as defined as the time from the date of initiation until the date of first documented progression. Revised tumor response criteria for lymphoma(Revised Cheson) or revised SWAT and assessed by MRI except a pregnant patient whose response evaluation can be assessed by CT scan: Progression is defined using these criteria, as observation of a new lesion or an increase of 50% or more from the nadir in a previously involved site.
Time frame: One-year
To Calculate the Duration of Response
The duration of response was assessed in 12 patients who had objective responses. The response continued even after the completion of the planned 16 cycles of brentuximab vedotin administration in three of these 12 patients (25%) at the time of data cut-off.
Time frame: From the first dose Up to the time of data cut-off.
To Calculate Overall Survival (OS) Time
OS as defined as the time from the date of first dose until death due to any cause. The median overall survival was obtained, but the upper value of 95% Confidence Interval was not reached at the time of data cut-off. Therefore the longest OS was 30.4 months, the follow-up duration up to the date of data cut-off.
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Time frame: From first dose to end of data collection