HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma
| Registry | NCT01356680 |
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| Status | Completed |
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| Phase | Phase 3 |
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| Study type | Interventional; randomized, parallel, masking: none, treatment |
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| Enrollment | 1100 (Actual) |
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| Sponsor | University of Cologne (Other) |
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| Conditions | Hodgkin Lymphoma |
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| Interventions | 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) (Drug, radiation) |
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| Dates | start 2012-01-13, primary completion 2020-03-21, completion 2020-03-23, first posted 2011-05-19, last updated 2020-04-06 |
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| Locations | 1 site in Germany |
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Related Papers Related Patents Related Grants Related Experts
All trials for Hodgkin Lymphoma All trials of BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone) All trials of ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)
-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).
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Arm A | Active comparator | Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone); Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine); Radiation: 30Gy IF-RT (Involved-Field Radiotherapy) | 2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy |
| Arm B | Experimental | Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone); Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine); Radiation: 30Gy IN-RT (Involved-Node Radiotherapy) | 2 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 |
- 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)
+Outcome measures
Primary outcomes
- Progression Free Survival [3 years]
Secondary outcomes
- Overall Survival [3 years]
- CR rate [6 months]: Rate of patients achieving a complete remission (CR/CRu) at final restaging after completion of study treatment
+Eligibility
Sex: All, ages: 18 Years to 60 Years
Inclusion Criteria:
* 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
Exclusion Criteria:
* Leucocytes <3000/µl
* Platelets < 100000/µl
* Hodgkin Lymphoma as composite lymphoma
* Activity Index (WHO) >2
+Locations (1)
| Facility | City | Country | Status |
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| 1st Dept. of Medicine, Cologne University Hospital | Cologne | Germany | |
+Publications
- Results publication: 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
- Results publication: 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
- Results publication: 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. PMID 37644732
- Results publication: 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. PMID 33539742
- Results publication: 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
+Investigators