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Hodgkin LymphomaPhase 3NCT01356680

HD17 for Intermediate Stage Hodgkin Lymphoma

A Phase 3 study testing BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone), ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine) and 30Gy IF-RT (Involved-Field Radiotherapy) in people with Hodgkin Lymphoma, run by University of Cologne at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone), ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine) and 30Gy IF-RT (Involved-Field Radiotherapy)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,100 participants
Where
1 siteGermany
Study dates
13 Jan 2012to 23 Mar 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Hodgkin Lymphoma
  • CS I, II with risk factor (stage IIB with risk factor 1 or 2 are not included)
  • large mediastinal mass (>1/3 of maximum transverse thorax diameter)
  • extranodal involvement
  • elevated ESR
  • 3 or more involved nodal areas
  • written informed consent

Who cannot join

  • Leucocytes <3000/µl
  • Platelets < 100000/µl
  • Hodgkin Lymphoma as composite lymphoma
  • Activity Index (WHO) >2

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • 1st Dept. of Medicine, Cologne University Hospital

    Cologne

Other trials in Germany

About this study

Official title: HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma

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).

Being tested
BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone), ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine), 30Gy IF-RT (Involved-Field Radiotherapy), 30Gy IN-RT (Involved-Node Radiotherapy)
Keywords
Hodgkin Lymphoma, intermediate stage, PET
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)Drug

  • ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)Drug

  • 30Gy IF-RT (Involved-Field Radiotherapy)Radiation

  • 30Gy IN-RT (Involved-Node Radiotherapy)Radiation

Study groups in NCT01356680
Study groupRoleWhat they receive
Arm AActive comparator2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy
Receives: Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone); Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine); Radiation: 30Gy IF-RT (Involved-Field Radiotherapy)
Arm BExperimental2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IN-RT if FDG-PET is positive after chemotherapy; 2 cycles BEACOPPescalated plus 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy
Receives: Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone); Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine); Radiation: 30Gy IN-RT (Involved-Node Radiotherapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Measured: 3 years

Secondary outcomes (2)

  1. Overall Survival

    Measured: 3 years

  2. CR rate

    Rate of patients achieving a complete remission (CR/CRu) at final restaging after completion of study treatment

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2011 (estimated)
  2. Study start13 Jan 2012
  3. Primary completion21 Mar 2020
  4. Study completion23 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01356680
Sponsor's protocol ID
HD17
Status last verified
Apr 2020
First submitted
13 May 2011
Last updated
6 Apr 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 41074963

  • 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.

    PubMed 40135712

  • van Heek L, Weindler J, Gorniak C, Kaul H, Muller H, Mettler J, Baues C, Fuchs M, Borchmann P, Ferdinandus J, Dietlein M, Voltin CA, Kobe C, Roth KS. Prognostic value of baseline metabolic tumor volume (MTV) for forecasting chemotherapy outcome in early-stage unfavorable Hodgkin lymphoma: Data from the phase III HD17 trial. Eur J Haematol. 2023 Dec;111(6):881-887. doi: 10.1111/ejh.14093. Epub 2023 Aug 29.

    PubMed 37644732

  • Borchmann P, Plutschow A, Kobe C, Greil R, Meissner J, Topp MS, Ostermann H, Dierlamm J, Mohm J, Thiemer J, Sokler M, Kerkhoff A, Ahlborn M, Halbsguth TV, Martin S, Keller U, Balabanov S, Pabst T, Vogelhuber M, Huttmann A, Wilhelm M, Zijlstra JM, Moccia A, Kuhnert G, Brockelmann PJ, von Tresckow B, Fuchs M, Klimm B, Rosenwald A, Eich H, Baues C, Marnitz S, Hallek M, Diehl V, Dietlein M, Engert A. PET-guided omission of radiotherapy in early-stage unfavourable Hodgkin lymphoma (GHSG HD17): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):223-234. doi: 10.1016/S1470-2045(20)30601-X.

    PubMed 33539742

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone), ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine) and 30Gy IF-RT (Involved-Field Radiotherapy) in people with Hodgkin Lymphoma, run by University of Cologne at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01356680, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.

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