Hodgkin Lymphom

Short title: HD 21

Title: HD21 for advanced stages: Treatment optimization trial in the first-line treatment of advanced stage Hodgkin lymphoma; comparison of 4-6 cycles of escalated BEACOPP with 4-6 cycles of BrECADD

Status: open (only for elderly cohort), randomised main study is active, not recruiting

Start: April 2017 (in Austria)

Coordinating Investigator: Univ. Prof. Dr. Richard Greil

EudraCT Number: 2014-005130-55

ClinicalTrialsID: NCT02661503

Number of patients: 1585 (international), 90 (national)

Sponsor: GHSG (German Hodgkin Studygroup), AGMT Sponsor representative in Austria

In this prospective, multicenter, randomized and open-label trial, patients in the standard group are treated with either 4 or 6 cycles of escalated BEACOPP according to the results of the interim staging (PET-2 negative patients receive 4 cycles of escalated BEACOPP, PET-2 positive patients receive 6 cycles of escalated BEACOPP) . Patients in the experimental group receive either 4 or 6 cycles of the BrECADD chemotherapy regimen, again according to the results of the interim staging (PET-2 negative patients receive 4 cycles of BrECADD, PET-2 positive patients receive 6 cycles of BrECADD).

In both groups, patients with PET positive residual tumor masses at the end of chemotherapy according to PET-4 or PET-6 are subjected to local irradiation with 30 Gy.

Patients without signs of active tumor at restaging after chemotherapy do not receive any further treatment and directly enter the follow-up program.

Assessments from the interim staging and the restaging after chemotherapy (without regard to the number of administered treatment cycles) are reviewed in Cologne.

Elderly cohort (61 – 75 years) was added and will be treated without randomisation in the BrECADD arm.

Short title: AERN

Title: AERN – Abscopal Effect of Radiotherapy and Nivolumab in anti-PD1 Pretreated Relapsed or Refractory classical Hodgkin Lymphoma – An international multicenter Phase II trial

Status: planned

Start: Dezember 2020 (in Austria)

Coordinating Investigator: Univ. Prof. Dr. Richard Greil

EudraCT Number: 2017-003334-82

ClinicalTrialsID: NCT03480334

Number of patients: 29 (international), 4 (national)

Sponsor: GHSG (German Hodgkin Studygroup), AGMT Sponsor representative in Austria

The aim of the trial is to improve efficacy of nivolumab in patients with relapsed or refractory HL who recently progressed on anti-PD1 therapy. Nivolumab is highly effective and well tolerated in rrHL, nevertheless CR-rates are low and a considerable proportion of patients suffers from progressive disease. Localized RT induces an immunogenic effect which might work synergistically and facilitate augmented systemic (i.e. abscopal) responses in combination with nivolumab.

The primary objective of the trial is to show efficacy of the experimental treatment strategy. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.