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
- HD 21
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
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.
- Progression free survival and treatment related morbidity (TRMB)
- CR rate after completion of chemotherapy
- Overall survival
- Infertility rate at 1 yera (determined by hormone levels)
- Second malignancies
- Number of serious adverse events within 30 days after end of treatment
- Therapy adherence
- Quality of life before, during and after therapy
Inclusion / Exclusion criteria
Inclusion criteria (selected):
- Histologically proven classical Hodgkin lymphoma
- Patient has had no previous treatment for HL
- Age at entry: 18 – 60 years (61 – 75 years for elderly cohort)
- CS (PS) IIB with large mediastinal mass, extra nodal disease or CS (PS) III; IV
- Normal organ function (except for HL-related functional disorders)
- Estimated life expectancy > 3 months
- In women: negative pregnancy test
Exclusion criteria (selected):
- Nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) or composite lymphoma
- Malignant disease within the last 5 years (Exceptions: basalioma, carcinoma in situ e.g. of the cervix uteri, completely resected melanoma TNMpT1)
- Chemotherapy or radiotherapy in medical history
- ECOG >2
- Long-term administration (> 6 months) of corticosteroids or antineoplastic drugs
- Peripheral neuropathy > CTCAE grade 1
- Unsafe contraception