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.