NCT01356680

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

January 13, 2012

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2020

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

8.2 years

First QC Date

May 13, 2011

Last Update Submit

April 3, 2020

Conditions

Hodgkin Lymphoma

Keywords

Hodgkin Lymphomaintermediate stagePET

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    3 years

Secondary Outcomes (2)

  • Overall Survival

    3 years

  • CR rate

    6 months

Study Arms (2)

Arm A

ACTIVE COMPARATOR

2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy

Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)Radiation: 30Gy IF-RT (Involved-Field Radiotherapy)

Arm B

EXPERIMENTAL

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

Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)Radiation: 30Gy IN-RT (Involved-Node Radiotherapy)

Interventions

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • or more involved nodal areas
  • written informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1st Dept. of Medicine, Cologne University Hospital

Cologne, Germany

Location

Related Publications (5)

  • 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. 2025 Oct 11. doi: 10.1007/s00259-025-07569-5. Online ahead of print.

    PMID: 41074963DERIVED

  • 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: 40135712DERIVED

  • 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: 37644732DERIVED

  • 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: 33539742DERIVED

  • 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: 30010775DERIVED

Related Links

MeSH Terms

Conditions

Hodgkin Disease

Interventions

BleomycinEtoposideDoxorubicinCyclophosphamideVincristineProcarbazinePrednisoneABVD protocolVinblastineDacarbazine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesDaunorubicinAnthracyclinesNaphthacenesAminoglycosidesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesBenzamidesAmidesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsTriazenesImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Andreas Engert, Prof.

    University of Cologne, German Hodgkin Study Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

May 13, 2011

First Posted

May 19, 2011

Study Start

January 13, 2012

Primary Completion

March 21, 2020

Study Completion

March 23, 2020

Last Updated

April 6, 2020

Record last verified: 2020-04

Locations

DE(1)