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HD18 for Advanced Stages in Hodgkins Lymphoma

NCT ID: NCT00515554

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2020-07-31

Brief Summary

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This study is designed to test:

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

Detailed Description

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Conditions

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Hodgkins Lymphoma

Keywords

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Hodgkin lymphoma PET advances stages Rituximab

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

8 cycles BEACOPPesc

Group Type ACTIVE_COMPARATOR

BEACOPP escalated

Intervention Type DRUG

chemotherapy with BEACOPP escalated

B

8 cycles BEACOPPesc plus rituximab

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

addition of Rituximab to BEACOPP escalated

BEACOPP escalated

Intervention Type DRUG

chemotherapy with BEACOPP escalated

C

8 cycles BEACOPPesc

Group Type ACTIVE_COMPARATOR

BEACOPP escalated

Intervention Type DRUG

chemotherapy with BEACOPP escalated

D

4 cycles BEACOPPesc

Group Type EXPERIMENTAL

BEACOPP escalated

Intervention Type DRUG

chemotherapy with BEACOPP escalated

Interventions

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Rituximab

addition of Rituximab to BEACOPP escalated

Intervention Type DRUG

BEACOPP escalated

chemotherapy with BEACOPP escalated

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Andreas Engert

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Engert, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

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1st Dept. of Medicine, Cologne University Hospital

Cologne, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 41074963 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40135712 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34048679 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30166329 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30010775 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29061295 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28236583 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23225085 (View on PubMed)

Other Identifiers

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HD18

Identifier Type: -

Identifier Source: org_study_id