Study on the Role of Brentuximab Vedotin as Single Agent in the Treatment of Relapsed/Refractory CD30+ PTCL Patients
NCT02497131 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2022-03-22
Summary
This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of Brentuximab Vedotin (BV) as a single agent in relapsed/refractory CD30+ PTCL patients.
Conditions
- Lymphatic Diseases
Interventions
- DRUG
-
Brentuximab Vedotin
Brentuximab vedotin will be administered on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg and is administered by outpatient IV infusion given over approximately 30 minutes
Sponsors & Collaborators
-
Fondazione Italiana Linfomi - ETS
lead OTHER
Principal Investigators
-
Vittorio Stefoni, MD · Ematologia "L. & A. Seragnoli" - Policlinico S. Orsola Malpighi
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-21
- Primary Completion
- 2019-09-24
- Completion
- 2022-03-31
Countries
- Italy
Study Locations
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