HD16 for Early Stage Hodgkin Lymphoma

Conditions

Hodgkin Lymphoma

Keywords

Hodgkin Lymphoma, early stage, PET

Brief summary

This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS).

Lommen M, Weindler JJ, Jablonski J, Rosenbrock J, Borchmann P, Behringer K, Roth KS, Ufton D, Dietlein M, Kobe C, Ferdinandus J.

2025-10-11

10.1007/s00259-025-07569-5

Predictive value of baseline metabolic tumor volume in early-stage favorable Hodgkin Lymphoma - Data from the prospective, multicenter phase III HD16 trial.

van Heek L, Stuka C, Kaul H, Müller H, Mettler J, Hitz F, Baues C, Fuchs M, Borchmann P, Engert A, Dietlein M, Voltin CA, Kobe C.

2022-06-1824 citations

10.1186/s12885-022-09758-z

Involved-Field Radiation Therapy Prevents Recurrences in the Early Stages of Hodgkin Lymphoma in PET-Negative Patients After ABVD Chemotherapy: Relapse Analysis of GHSG Phase 3 HD16 Trial.

Baues C, Goergen H, Fuchs M, Rosenbrock J, Celik E, Eich H, Kobe C, Voltin CA, Engert A, Borchmann P, Marnitz S.

2021-08-115 citations

10.1016/j.ijrobp.2021.07.1697

Value of bone marrow biopsy in Hodgkin lymphoma patients staged by FDG PET: results from the German Hodgkin Study Group trials HD16, HD17, and HD18

Conrad‐Amadeus Voltin, Helen Goergen, Christian Baues, Michael Fuchs, Jasmin Mettler et al. (14 authors)

Annals of Oncology2018-07-1356 citations

10.1093/annonc/mdy250

Interventions

DRUGABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)

chemotherapy with 2 cycles of ABVD (day 1 + 15)

RADIATION20 Gy IFRT (Involved Field Radiotherapy)

20 Gy Involved Field Radiotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

* Hodgkin Lymphoma * CS I, II without risk factors * large mediastinal mass (\> 1/3 of maximum transverse thorax diameter) * extranodal involvement * elevated ESR * 3 or more involved nodal areas * Written informed consent

Exclusion criteria

* Leucocytes \< 3000/µl * Platelets \< 100000/µl * Hodgkin Lymphoma as composite lymphoma * Activity index (WHO) \> 2

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	5 years

Secondary

Measure	Time frame
overall survival	5 years
acute toxicity	5 years
late toxicity	5 years
CR rate	5 years

Countries

Germany

Outcome results

None listed