Brentuximab Vedotin Followed by ABVD in Patients With Previously Untreated Hodgkin Lymphoma
NCT02275598 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2014-10-27
Summary
The purpose of this study is to assess the efficacy of two three-weekly 1.8 mg/kg Brentuximab vedotin administrations in untreated patients with Hodgkin Lymphoma (HL).
Conditions
Interventions
- DRUG
-
Brentuximab vedotin
1.8 mg/kg, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: 2
- DRUG
-
ABVD
Doxorubicin 25 mg/m2 IV, Bleomycin 10,000 units/m2 IV, Vinblastine 6 mg/m2 IV, Dacarbazine 375 mg/m2 IV on days 1-15 of each 28 day cycle. Number of Cycles: 3 or 6 according to initial disease stage.
Sponsors & Collaborators
-
Millennium Pharmaceuticals, Inc.
collaborator INDUSTRY -
University of Modena and Reggio Emilia
lead OTHER
Principal Investigators
-
Massimo Federico, MD · Department of Diagnostic, Clinical and Public Health Medicine
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 8 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-04-30
- Primary Completion
- 2013-11-30
- Completion
- 2015-03-31
Countries
- Italy
Study Locations
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