HD21 for Advanced Stages

NCT02661503 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: Uni-Koeln-17622014-005130-55
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective of the trial is to demonstrate non-inferior efficacy of six cycles of BrECADD compared to six cycles of escalated BEACOPP, each followed by radiotherapy to PET-positive residual lesions ≥2.5 cm, in terms of progression free survival (efficacy objective). If non-inferior efficacy can be shown, the co-primary objective is to further demonstrate reduced toxicity of the BrECADD treatment compared to the escalated BEACOPP treatment measured by treatment related morbidity (TRMorbidity objective).

Conditions

Classical Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival

  5 years

• Treatment Related Morbidity

  during 6 cycles of chemotherapy (21-day cycles)

Study Arms (2)

BEACOPP

ACTIVE COMPARATOR

4 or 6 cycles of BEACOPP (21-day cycles) Bleomycin (B) Etoposide (E) Doxorubicin (A) Cyclophosphamide (C) Vincristine (O) Procarbazin (P) Prednisone (P). If FDG-PET is negative after two cycles patients will be given a total of four cycles. If FDG-PET is positive after two cycles patients will bev given a total of six cycles.

Drug: Bleomycin; Drug: Etoposide; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Procarbazine; Drug: Prednisone

BRECADD

EXPERIMENTAL

4 or 6 cycles of BRECADD (21.day cycles) Brentuximab Vedotin (BR) Etoposide (E) Cyclophosphamide (C) Doxorubicin (A) Dacarbazine (D) Dexamethasone (D). If FDG-PET is negative after two cycles patients will be given a total of four cycles. If FDG-PET is positive after two cycles patients will be given a total of six cycles.

Drug: Etoposide; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Brentuximab Vedotin; Drug: Dacarbazine; Drug: Dexamethasone

Interventions

Bleomycin DRUG

BEACOPP

Etoposide DRUG

BEACOPP; BRECADD

Doxorubicin DRUG

BEACOPP; BRECADD

Cyclophosphamide DRUG

BEACOPP; BRECADD

Vincristine DRUG

BEACOPP

Procarbazine DRUG

BEACOPP

Prednisone DRUG

BEACOPP

Brentuximab Vedotin DRUG

BRECADD

Dacarbazine DRUG

BRECADD

Dexamethasone DRUG

BRECADD

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Histologically proven classical Hodgkin lymphoma
• First diagnosis, no previous treatment, 18 to 60 years of age
• Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV

You may not qualify if:

• Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma
• Previous malignancy (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)
• Prior chemotherapy or radiotherapy

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University Hospital of Cologne

Cologne, Germany

Location

Related Publications (4)

• Ferdinandus J, Kaul H, Fossa A, Huttmann A, Keil F, Ko YD, Hitz F, Schwarz M, Trenker C, Kerkhoff A, Staib P, Wille K, Dresel I, Hahn D, Hertenstein B, Moosmann P, Mey U, Balabanov S, Armytage T, Roncolato F, Hellmuth JC, Hertzberg M, Kobe C, Klapper W, Baues C, Eich HT, Kreissl S, Fuchs M, Jablonski J, Schneider G, Tharmaseelan H, Eichenauer DA, von Tresckow B, Borchmann P, Brockelmann PJ. Positron Emission Tomography-Guided Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, and Dexamethasone in Older Patients With Advanced-Stage Classic Hodgkin Lymphoma: A Prospective, Multicenter, Single-Arm, Phase II Cohort of the German Hodgkin Study Group HD21 Trial. J Clin Oncol. 2025 Sep 20;43(27):2974-2985. doi: 10.1200/JCO-25-00439. Epub 2025 Jul 17.

  PMID: 40674676 DERIVED

• Ferdinandus J, Schneider G, Moccia A, Greil R, Hertzberg M, Schaub V, Huttmann A, Keil F, Dierlamm J, Hanel M, Novak U, Meissner J, Hellmuth JC, Mathas S, Zijlstra JM, Fossa A, Viardot A, Hertenstein B, Martin S, Giri P, Kamper P, Molin D, Jablonski J, Damaschin C, Robertz AS, Rosenbrock J, Fuchs M, Borchmann P, Behringer K. Fertility in patients with advanced-stage classic Hodgkin lymphoma treated with BrECADD versus eBEACOPP: a secondary analysis of the multicentre, randomised, parallel, open-label, phase 3 HD21 trial. Lancet Oncol. 2025 Aug;26(8):1081-1090. doi: 10.1016/S1470-2045(25)00262-1. Epub 2025 Jul 10.

  PMID: 40652943 DERIVED

• Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.

  PMID: 40135712 DERIVED

• Borchmann P, Ferdinandus J, Schneider G, Moccia A, Greil R, Hertzberg M, Schaub V, Huttmann A, Keil F, Dierlamm J, Hanel M, Novak U, Meissner J, Zimmermann A, Mathas S, Zijlstra JM, Fossa A, Viardot A, Hertenstein B, Martin S, Giri P, Scholl S, Topp MS, Jung W, Vucinic V, Beck HJ, Kerkhoff A, Unger B, Rank A, Schroers R, Zum Buschenfelde CM, de Wit M, Trautmann-Grill K, Kamper P, Molin D, Kreissl S, Kaul H, von Tresckow B, Borchmann S, Behringer K, Fuchs M, Rosenwald A, Klapper W, Eich HT, Baues C, Zomas A, Hallek M, Dietlein M, Kobe C, Diehl V; German Hodgkin Study Group; Swiss Group for Clinical Cancer Research; Arbeitsgemeinschaft Medikamentose Tumortherapie; Nordic Lymphoma Group; Australasian Leukaemia and Lymphoma Group. Assessing the efficacy and tolerability of PET-guided BrECADD versus eBEACOPP in advanced-stage, classical Hodgkin lymphoma (HD21): a randomised, multicentre, parallel, open-label, phase 3 trial. Lancet. 2024 Jul 27;404(10450):341-352. doi: 10.1016/S0140-6736(24)01315-1. Epub 2024 Jul 3.

  PMID: 38971175 DERIVED

MeSH Terms

Interventions

Bleomycin; Etoposide; Doxorubicin; Cyclophosphamide; Vincristine; Procarbazine; Prednisone; Brentuximab Vedotin; Dacarbazine; Dexamethasone

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Oligopeptides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Pregnadienetriols; Steroids, Fluorinated

Study Officials

• Peter Borchmann, Prof.

  University of Cologne, I. Dept. of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: January 22, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: September 1, 2025
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

DE (1)