NCT01356680 · CITED IN SOURCE DOCUMENTS

HD17 for Intermediate Stage Hodgkin 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: 2020-04-06

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).

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 * 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
healthy Volunteers: false
maximum Age: 60 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT

Treatment arms and interventions

arm Groups

description
2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy
intervention Names
Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)
Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)
Radiation: 30Gy IF-RT (Involved-Field Radiotherapy)
label
Arm A
type
ACTIVE_COMPARATOR
description
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
intervention Names
Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)
Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)
Radiation: 30Gy IN-RT (Involved-Node Radiotherapy)
label
Arm B
type
EXPERIMENTAL

interventions

arm Group Labels
Arm A
Arm B
name
BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)
type
DRUG
arm Group Labels
Arm A
Arm B
name
ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)
type
DRUG
arm Group Labels
Arm A
name
30Gy IF-RT (Involved-Field Radiotherapy)
type
RADIATION
arm Group Labels
Arm B
name
30Gy IN-RT (Involved-Node Radiotherapy)
type
RADIATION

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 1100
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Progression Free Survival
time Frame
3 years

secondary Outcomes

measure
Overall Survival
time Frame
3 years
description
Rate of patients achieving a complete remission (CR/CRu) at final restaging after completion of study treatment
measure
CR rate
time Frame
6 months

Full study description

brief 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).

Source references

references

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
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
citation
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
type
DERIVED
citation
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
type
DERIVED
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