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NCT00515554 · CITED IN SOURCE DOCUMENTS

HD18 for Advanced Stages in Hodgkins Lymphoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2020-11-13

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
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: * Leucocytes \< 3000/µl * Platelets \< 100000/µl * Hodgkin´s lymphoma as "composite lymphoma" * Activity index (WHO) \< grade 2
healthy Volunteers
false
maximum Age
60 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
Treatment arms and interventions
arm Groups
  1. description
    8 cycles BEACOPPesc
    intervention Names
    1. Drug: BEACOPP escalated
    label
    A
    type
    ACTIVE_COMPARATOR
  2. description
    8 cycles BEACOPPesc plus rituximab
    intervention Names
    1. Drug: Rituximab
    2. Drug: BEACOPP escalated
    label
    B
    type
    EXPERIMENTAL
  3. description
    8 cycles BEACOPPesc
    intervention Names
    1. Drug: BEACOPP escalated
    label
    C
    type
    ACTIVE_COMPARATOR
  4. description
    4 cycles BEACOPPesc
    intervention Names
    1. Drug: BEACOPP escalated
    label
    D
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. B
    description
    addition of Rituximab to BEACOPP escalated
    name
    Rituximab
    type
    DRUG
  2. arm Group Labels
    1. A
    2. B
    3. C
    4. D
    description
    chemotherapy with BEACOPP escalated
    name
    BEACOPP escalated
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1500
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Progression Free Survival
    time Frame
    5 years
secondary Outcomes
  1. measure
    Overall Survival
    time Frame
    5 years
  2. measure
    acute toxicity
    time Frame
    5 years
  3. measure
    late toxicity
    time Frame
    5 years
  4. measure
    CR-rate
    time Frame
    5 years
Full study description
brief 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.
Source references
references
  1. citation
    Leiders S, Ufton D, Kaul H, Weindler J, Rosenbrock J, Fuchs M, Dietlein M, Novak U, Fehr M, Greil R, Hertzberg M, Zijlstra JM, Fossa A, Kamper P, Molin D, Borchmann P, Kobe C, Ferdinandus J. Validation of the newly introduced Deauville Score 5a in patients treated for advanced-stage classic Hodgkin Lymphoma. Blood Adv. 2026 Jun 30:bloodadvances.2026019712. doi: 10.1182/bloodadvances.2026019712. Online ahead of print.
    pmid
    42379221
    type
    DERIVED
  2. citation
    Lommen M, Weindler JJ, Jablonski J, Rosenbrock J, Borchmann P, Behringer K, Roth KS, Ufton D, Dietlein M, Kobe C, Ferdinandus J. Association between metabolic tumor burden and health-related quality of life in patients with classic Hodgkin lymphoma. Eur J Nucl Med Mol Imaging. 2026 Feb;53(3):1847-1855. doi: 10.1007/s00259-025-07569-5. Epub 2025 Oct 11.
    pmid
    41074963
    type
    DERIVED
  3. citation
    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
    type
    DERIVED
  4. citation
    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.
    pmid
    34048679
    type
    DERIVED
  5. citation
    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.
    pmid
    30166329
    type
    DERIVED
  6. citation
    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.
    pmid
    30010775
    type
    DERIVED
  7. citation
    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.
    pmid
    29061295
    type
    DERIVED
  8. citation
    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.
    pmid
    28236583
    type
    DERIVED
  9. citation
    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.
    pmid
    23225085
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        ative predictive value for PET was 94% [95% CI, 91%&#8211;97%]).[<a href="#cit/section_7.22">22</a>] In the German Hodgkin Study Group <a href="/clinicaltrials/NCT00515554">HD18</a> trial (NCT00515554), PET scan negativity after two cycles (PET2) of escalated BEACOPP allowed reduction to four cycles of therapy instead of six or
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        T was 94% [95% CI, 91%&#8211;97%]).[<a href="#cit/section_7.22">22</a>] In the German Hodgkin Study Group <a href="/clinicaltrials/NCT00515554">HD18</a> trial (NCT00515554), PET scan negativity after two cycles (PET2) of escalated BEACOPP allowed reduction to four cycles of therapy instead of six or eight cycles because of the
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      source title
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      source update dates
      1. context
        Updated: February 12, 2025
        datetime
        2025-02-12T12:00:00Z
        display
        February 12, 2025

    Preserved source evidence · Not medical advice