NCT02298283

Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II HL and PET Positivity After 2 Cycles of ABVD

Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II Hodgkin's Lymphoma and FDG-PET Positivity After 2 Cycles of ABVD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: The Lymphoma Academic Research Organisation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	brentuximab vedotin	is 1.8 mg/kg administrated by IV infusion
DRUG	Cyclophosphamide	1250 mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks
DRUG	Adriamycin	35mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks
DRUG	Oncovin	1.4 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks
DRUG	Bleomycin	10 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks
DRUG	Etoposide	200 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D3 of 2 BEACOPP cycles, every 3 weeks
DRUG	Procarbazine	100 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D7 of 2 BEACOPP cycles, every 3 weeks
DRUG	Prednisone	40 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D7 of 2 BEACOPP cycles, every 3 weeks
DRUG	G-CSF	5 µg/kg/j, SC, D9 until GB 1.0x109/L
RADIATION	30 Grays	30 Gy radiation of sites initially diagnoses + 6Gy for residual sites, 3 to 4 weeks after D1 of BEACOPP cycle 2.

Timeline

• Start date: 2015-04-01
• Primary completion: 2020-07-09
• Completion: 2020-07-09
• First posted: 2014-11-21
• Last updated: 2021-07-26

Locations

30 sites across 1 country: France