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Clinical Trial Results:
BRENTUXIMAB VEDOTIN ASSOCIATED WITH CHEMOTHERAPY IN UNTREATED PATIENTS WITH STAGE I/II UNFAVOURABLE HODGKIN LYMPHOMA - A RANDOMIZED PHASE II LYSA-FIL-EORTC INTERGROUP STUDY

Summary
EudraCT number	2013-000182-37
Trial protocol	FR BE IT DK NL HR
Global end of trial date	02 Jun 2022

Results information
Results version number	v1(current)
This version publication date	20 Oct 2022
First version publication date	20 Oct 2022
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
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Trial information

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Sponsor protocol code

BREACH

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

LYSARC

Sponsor organisation address

Centre Hospitalier Lyon-Sud Bâtiment 2D , Pierre Benite Cedex, France,

Public contact

Co-coordinating Investigator, Dr Luc-Matthieu Fornecker, 33 388127676, luc-matthieu.fornecker@chru-strasbourg.fr

Scientific contact

Co-coordinating Investigator, Dr Luc-Matthieu Fornecker, 33 388127676, luc-matthieu.fornecker@chru-strasbourg.fr

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

08 Dec 2020

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

02 Jun 2022

Was the trial ended prematurely?

Main objective of the trial

To assess the efficacy of the combination AVD+brentuximab vedotin in untreated patients with stage I/II unfavourable Hodgkin lymphoma, as measured by the rate of PET negativity after two cycles of immuno chemotherapy, PET assessment based on central review.

Protection of trial subjects

Appropriate precautions should be taken during infusion of the drug, with regular monitoring of vital signs, drugs available for the treatment of anaphylactic reaction, and a physician in attendance. Patients treated with brentuximab vedotin should be monitored closely during the infusion and be advised of the potential to develop allergy-like symptoms post-infusion. Infusion-related reactions may occur during the infusion of study treatment. The infusion is to be administered at a site properly equipped and staffed to manage anaphylaxis should it occur. The patient should be observed for at least 60 minutes following the first infusion of study treatment. During this observation period, the IV line should remain open for at least 1 hour to allow administration of IV drugs if necessary. All supportive measures consistent with optimal patient care will be given throughout the study according to institutional standards. This includes adjusting the infusion time if necessary. Medications for infusion-related reactions should be available for immediate use. Routine premedication should not be administered prior to the first dose of study treatment. But, patients who experience an infusion-related reaction (any grade) may receive subsequent study treatment infusions with premedication consisting of paracetamol, an antihistaminic (e.g. diphenhydramine 25–50 mg orally or 10–25 mg IV), epinephrine and corticosteroids or according to institutional standards, administered 30–60 minutes prior to each 30-minute infusion. The use of prophylactic hydrocortisone or other steroids is also allowed.

Background therapy

Evidence for comparator

ABVD is used as a reference group to confirm study hypothesis and not as a comparator arm.

Actual start date of recruitment

01 Sep 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country