NCT00515554

Brief Summary

This study is designed to test:

  1. 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. 2.for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc chemotherapy by adding Rituximab improves PFS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2008

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

August 10, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2007

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

11.2 years

First QC Date

August 10, 2007

Last Update Submit

November 11, 2020

Conditions

Hodgkins Lymphoma

Keywords

Hodgkin lymphomaPETadvances stagesRituximab

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    5 years

Secondary Outcomes (4)

  • Overall Survival

    5 years

  • acute toxicity

    5 years

  • late toxicity

    5 years

  • CR-rate

    5 years

Study Arms (4)

A

ACTIVE COMPARATOR

8 cycles BEACOPPesc

Drug: BEACOPP escalated

B

EXPERIMENTAL

8 cycles BEACOPPesc plus rituximab

Drug: RituximabDrug: BEACOPP escalated

C

ACTIVE COMPARATOR

8 cycles BEACOPPesc

Drug: BEACOPP escalated

D

EXPERIMENTAL

4 cycles BEACOPPesc

Drug: BEACOPP escalated

Interventions

RituximabDRUG

addition of Rituximab to BEACOPP escalated

B
BEACOPP escalatedDRUG

chemotherapy with BEACOPP escalated

ABCD

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Leucocytes \< 3000/µl
  • Platelets \< 100000/µl
  • Hodgkin´s lymphoma as "composite lymphoma"
  • Activity index (WHO) \< grade 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1st Dept. of Medicine, Cologne University Hospital

Cologne, 50924, Germany

Location

Related Publications (8)

  • 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

  • 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: 34048679DERIVED

  • 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: 30166329DERIVED

  • 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

  • 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: 29061295DERIVED

  • 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: 28236583DERIVED

  • 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: 23225085DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Rituximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Andreas Engert, Prof.

    University of Cologne

    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

August 10, 2007

First Posted

August 13, 2007

Study Start

May 1, 2008

Primary Completion

July 1, 2019

Study Completion

July 1, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations

DE(1)