NCT02292979

Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Hodgkin Lymphoma.

Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Stage I/II Unfavourable Hodgkin Lymphoma. A Randomized Phase II LYSA-FIL-EORTC Intergroup Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: The Lymphoma Academic Research Organisation · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients will receive either ABVD chemotherapy (standard treatment = doxorubicin, bleomycin, vinblastine, dacarbazine) or the Brentuximab vedotin in combination with chemotherapy AVD (study treatment), depending on randomization. Radiotherapy is planned after chemotherapy or immunochemotherapy. PET scans will be performed before inclusion, after 2 cycles of chemotherapy and after 4 cycles of chemotherapy (if PET after two cycles was positive), at the end of treatment and during follow-up period.

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Doxorubicin	25mg/m2
DRUG	Bleomycin	10mg/m2
DRUG	Vinblastine	6mg/m2
DRUG	Dacarbazine	375mg/m2
DRUG	Brentuximab Vedotin	1.2 mg/kg

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-12-01
• Completion: 2022-06-02
• First posted: 2014-11-18
• Last updated: 2022-08-19

Locations

65 sites across 5 countries: Belgium, Croatia, Denmark, France, Netherlands