Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Hodgkin Lymphoma.
NCT02292979 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170
Last updated 2022-08-19
Summary
This study aims to evaluate the efficacy of brentuximab vedotin + AVD combination (doxorubicine, vinblastine, dacarbazine) in patients with Hodgkin lymphoma stage I / II with an unfavorable diagnosis, assessed by the negativity of PET (positron emission tomography ) after two cycles of chemotherapy.
Conditions
Interventions
- DRUG
-
Doxorubicin
25mg/m2
- DRUG
-
Bleomycin
10mg/m2
- DRUG
-
Vinblastine
6mg/m2
- DRUG
-
Dacarbazine
375mg/m2
- DRUG
-
Brentuximab Vedotin
1.2 mg/kg
Sponsors & Collaborators
-
Millennium Pharmaceuticals, Inc.
collaborator INDUSTRY -
The Lymphoma Academic Research Organisation
lead OTHER
Principal Investigators
-
Marc André, Pr · Lymphoma Study Association
-
Luc Fornecker, Dr · Lymphoma Study Association
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-03-31
- Primary Completion
- 2016-12-31
- Completion
- 2022-06-02
Countries
- Belgium
- Croatia
- Denmark
- France
- Netherlands
Study Locations
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