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

Phase 2

Recruiting

• Conditions: CHEMOTHERAPY; UNFAVOURABLE HODGKIN LYMPHOMA; 10025319

• Registration Number: NL-OMON55642
• Lead Sponsor: YSARC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

* Histologically confirmed CD30+ classical Hodgkin lymphoma according to
local evaluation
* Supradiaphragmatic Ann Arbor clinical stage I or II
* Previously untreated
* PET scan without IV contrast at diagnosis available for central review with at
least one hypermetabolic lesion

Exclusion Criteria

* Histological diagnosis different from classical Hodgkin Lymphoma. Nodular
lymphocyte predominant subtypes (nodular paragranuloma or Poppema
paragranuloma) are excluded.
* Known cerebral or meningeal disease of any etiology, including signs or
symptoms of PML

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective:<br /><br>To improve the PET negativity after two cycles of immuno-chemotherapy<br /><br>Primary efficacy endpoint:<br /><br>PET 2 assessment according to the five-point scale Deauville criteria (Negative<br /><br>=1, 2, 3 and Positive = 4, 5), based on central review.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives:<br /><br>Secondary efficacy endpoint:<br /><br>- CR rate (according to Cheson 2007) at the end of treatment<br /><br>- Progression-free survival (PFS)<br /><br>- Overall survival<br /><br>Secondary safety endpoint:<br /><br>- Toxicity of brentuximab vedotin in combination with combined modality<br /><br>treatment</p><br>