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

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).

Conditions

• Hodgkin Lymphoma

Interventions

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.

Sponsors & Collaborators

• The Lymphoma Academic Research Organisation

  lead OTHER

Principal Investigators

• Pauline BRICE, MD · Lymphoma Study Association

• Thomas GASTINNE, MD · Lymphoma Study Association

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2020-07-09

Completion

2020-07-09

Countries

• France

Study Locations