This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in patients with stage I/II Hodgkin's lymphoma and 18-fluorodeoxyglucose (FDG) -PET positivity after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine).
This study aims to evaluate the progression free survival after treatment for patient with stage I/II supradiaphragmatic HL patient and PET positive after 2 courses of ABVD. The treatment consist of 3 phases : * induction treatment with 2 cycles every 3 weeks of bleomycin, etoposide, Adriamycin, cyclophosphamide, oncovin, procarbazine, and prednisone (BEACOPP) escalated * radiotherapy 30 Gy starting 3 to 4 weeks after last day of second course of BEACOPP-escalated * consolidation treatment with 8 cycles every 21 days of brentuximab vedotin
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
is 1.8 mg/kg administrated by IV infusion
1250 mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks
35mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks
CH Victor Dupouy
Argenteuil, France
Progression free survival (PFS)
PFS is defined as the time from the date of the first cycle of ABVD to the first observation of documented disease progression or death due to any cause.
Time frame: 2 years
Complete Response rate (CR rate)
according to Cheson 2007
Time frame: 35 weeks
Overall survival
Time frame: 4 years
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1.4 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks
10 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks
200 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D3 of 2 BEACOPP cycles, every 3 weeks
100 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D7 of 2 BEACOPP cycles, every 3 weeks
40 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D7 of 2 BEACOPP cycles, every 3 weeks
5 µg/kg/j, SC, D9 until GB 1.0x109/L
30 Gy radiation of sites initially diagnoses + 6Gy for residual sites, 3 to 4 weeks after D1 of BEACOPP cycle 2.
Polyclinique Bordeaux Nord
Bordeaux, France
Centre François Baclesse
Caen, France
CH de Chambéry
Chambéry, France
CH Sud Francilien
Corbeil-Essonnes, France
Hôpital Henri Mondor
Créteil, France
CHU de Dijon - Hôpital le Bocage
Dijon, France
Hôpital André Mignot
Le Chesnay, France
Clinique Victor Hugo
Le Mans, France
CHRU Lille - Hôpital Claude Huriez
Lille, France
...and 20 more locations