HD18 for Advanced Stages in Hodgkins Lymphoma

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ClinicalTrials.gov Identifier: NCT00515554

Recruitment Status : Completed

First Posted : August 13, 2007

Last Update Posted : November 13, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Prof. Dr. Andreas Engert, University of Cologne

Study Description

Brief Summary:

This study is designed to test:

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

Condition or disease	Intervention/treatment	Phase
Hodgkins Lymphoma	Drug: Rituximab Drug: BEACOPP escalated	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1500 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Actual Study Start Date :	May 2008
Actual Primary Completion Date :	July 2019
Actual Study Completion Date :	July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hodgkin Lymphoma Lymphoma

Drug Information available for: Rituximab

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Hodgkin Lymphoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: A 8 cycles BEACOPPesc	Drug: BEACOPP escalated chemotherapy with BEACOPP escalated
Experimental: B 8 cycles BEACOPPesc plus rituximab	Drug: Rituximab addition of Rituximab to BEACOPP escalated Drug: BEACOPP escalated chemotherapy with BEACOPP escalated
Active Comparator: C 8 cycles BEACOPPesc	Drug: BEACOPP escalated chemotherapy with BEACOPP escalated
Experimental: D 4 cycles BEACOPPesc	Drug: BEACOPP escalated chemotherapy with BEACOPP escalated

Outcome Measures

Primary Outcome Measures :

Progression Free Survival [ Time Frame: 5 years ]

Secondary Outcome Measures :

Overall Survival [ Time Frame: 5 years ]
acute toxicity [ Time Frame: 5 years ]
late toxicity [ Time Frame: 5 years ]
CR-rate [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00515554

Locations

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Germany
1st Dept. of Medicine, Cologne University Hospital
Cologne, Germany, 50924

Sponsors and Collaborators

University of Cologne

Investigators

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Principal Investigator:	Andreas Engert, Prof.	University of Cologne

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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.

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.

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Responsible Party:	Prof. Dr. Andreas Engert, Prof., University of Cologne
ClinicalTrials.gov Identifier:	NCT00515554
Other Study ID Numbers:	HD18
First Posted:	August 13, 2007 Key Record Dates
Last Update Posted:	November 13, 2020
Last Verified:	November 2020

Keywords provided by Prof. Dr. Andreas Engert, University of Cologne:


Hodgkin lymphoma PET advances stages Rituximab

Additional relevant MeSH terms:

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Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders	Immune System Diseases Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents

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