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CompletedNCT00515554Updated Nov 13, 2020

HD18 for Advanced Stages in Hodgkins Lymphoma

A Phase 3 interventional study of Rituximab and BEACOPP escalated in Hodgkins Lymphoma, sponsored by University of Cologne. Completed at 1 site in Germany. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-11-13.

Sponsored by University of Cologne · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,500
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This study is designed to test:

  1. in patients with negative positron-emission tomography (PET) after 2 cycles of BEACOPPesc chemotherapy: whether the number of cycles can be reduced without compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles)
  2. for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc chemotherapy by adding Rituximab improves PFS.
02

Conditions studied

  • Hodgkins Lymphoma

Keywords

  • Hodgkin lymphoma
  • PET
  • advances stages
  • Rituximab
03

In context

Lymphoma

5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 1,500 is above the median of 40 across 4,509 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

University of Cologne is the lead sponsor of 199 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Hodgkin Lymphoma (histologically proven)

  • CS (PS) IIB with one or both of the risk factors:

    • bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter)
    • extranodal involvement
  • CS (PS) III, IV
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • Leucocytes \< 3000/µl
  • Platelets \< 100000/µl
  • Hodgkin´s lymphoma as "composite lymphoma"
  • Activity index (WHO) \< grade 2
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,500 participants (actual)

Study arms

  • Active comparator
    A

    8 cycles BEACOPPesc

    Drug: BEACOPP escalated

  • Experimental
    B

    8 cycles BEACOPPesc plus rituximab

    Drug: Rituximab · Drug: BEACOPP escalated

  • Active comparator
    C

    8 cycles BEACOPPesc

    Drug: BEACOPP escalated

  • Experimental
    D

    4 cycles BEACOPPesc

    Drug: BEACOPP escalated

Interventions

  • DrugRituximab

    addition of Rituximab to BEACOPP escalated

  • DrugBEACOPP escalated

    chemotherapy with BEACOPP escalated

06

What researchers measure

Primary outcomes

  1. Progression Free Survival

    Time frame: 5 years

Secondary outcomes

  1. Overall Survival

    Time frame: 5 years

  2. acute toxicity

    Time frame: 5 years

  3. late toxicity

    Time frame: 5 years

  4. CR-rate

    Time frame: 5 years

07

Study locations

1 site
  • 1st Dept. of Medicine, Cologne University Hospital
    Cologne, 50924, Germany
08

References and documents

Publications

  • Kreissl S, Goergen H, Buehnen I, Kobe C, Moccia A, Greil R, Eichenauer DA, Zijlstra JM, Markova J, Meissner J, Feuring-Buske M, Soekler M, Beck HJ, Willenbacher W, Ludwig WD, Pabst T, Topp MS, Hitz F, Bentz M, Keller UB, Kuhnhardt D, Ostermann H, Hertenstein B, Aulitzky W, Maschmeyer G, Vieler T, Eich H, Baues C, Stein H, Fuchs M, Diehl V, Dietlein M, Engert A, Borchmann P; German Hodgkin Study Group. PET-guided eBEACOPP treatment of advanced-stage Hodgkin lymphoma (HD18): follow-up analysis of an international, open-label, randomised, phase 3 trial. Lancet Haematol. 2021 Jun;8(6):e398-e409. doi: 10.1016/S2352-3026(21)00101-0. PubMed 34048679 ↗
  • Kobe C, Goergen H, Baues C, Kuhnert G, Voltin CA, Zijlstra J, Hoekstra O, Mettler J, Drzezga A, Engert A, Borchmann P, Dietlein M. Outcome-based interpretation of early interim PET in advanced-stage Hodgkin lymphoma. Blood. 2018 Nov 22;132(21):2273-2279. doi: 10.1182/blood-2018-05-852129. Epub 2018 Aug 30. PubMed 30166329 ↗
  • Voltin CA, Goergen H, Baues C, Fuchs M, Mettler J, Kreissl S, Oertl J, Klaeser B, Moccia A, Drzezga A, Engert A, Borchmann P, Dietlein M, Kobe C. 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. Ann Oncol. 2018 Sep 1;29(9):1926-1931. doi: 10.1093/annonc/mdy250. PubMed 30010775 ↗
  • Borchmann P, Goergen H, Kobe C, Lohri A, Greil R, Eichenauer DA, Zijlstra JM, Markova J, Meissner J, Feuring-Buske M, Huttmann A, Dierlamm J, Soekler M, Beck HJ, Willenbacher W, Ludwig WD, Pabst T, Topp MS, Hitz F, Bentz M, Keller UB, Kuhnhardt D, Ostermann H, Schmitz N, Hertenstein B, Aulitzky W, Maschmeyer G, Vieler T, Eich H, Baues C, Stein H, Fuchs M, Kuhnert G, Diehl V, Dietlein M, Engert A. PET-guided treatment in patients with advanced-stage Hodgkin's lymphoma (HD18): final results of an open-label, international, randomised phase 3 trial by the German Hodgkin Study Group. Lancet. 2017 Dec 23;390(10114):2790-2802. doi: 10.1016/S0140-6736(17)32134-7. Epub 2017 Oct 20. PubMed 29061295 ↗
  • Borchmann P, Haverkamp H, Lohri A, Mey U, Kreissl S, Greil R, Markova J, Feuring-Buske M, Meissner J, Duhrsen U, Ostermann H, Keller U, Maschmeyer G, Kuhnert G, Dietlein M, Kobe C, Eich H, Baues C, Stein H, Fuchs M, Diehl V, Engert A. Progression-free survival of early interim PET-positive patients with advanced stage Hodgkin's lymphoma treated with BEACOPPescalated alone or in combination with rituximab (HD18): an open-label, international, randomised phase 3 study by the German Hodgkin Study Group. Lancet Oncol. 2017 Apr;18(4):454-463. doi: 10.1016/S1470-2045(17)30103-1. Epub 2017 Feb 22. PubMed 28236583 ↗
  • Sauer M, Plutschow A, Jachimowicz RD, Kleefisch D, Reiners KS, Ponader S, Engert A, von Strandmann EP. Baseline serum TARC levels predict therapy outcome in patients with Hodgkin lymphoma. Am J Hematol. 2013 Feb;88(2):113-5. doi: 10.1002/ajh.23361. Epub 2012 Dec 8. PubMed 23225085 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00515554
Lead sponsor
University of Cologne
Responsible party
Prof. Dr. Andreas Engert (Prof., University of Cologne) — Principal investigator
First posted
Aug 13, 2007
Start date
May 2008
Primary completion
Jul 2019
Completion
Jul 2020
Last update
Nov 13, 2020

Study contacts

Andreas Engert, Prof.
principal investigator · University of Cologne

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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