HD18 for Advanced Stages in Hodgkins Lymphoma

• ClinicalTrials.gov Identifier: NCT00515554
• Recruitment Status: Completed
• First Posted: August 13, 2007
• Last Update Posted: November 13, 2020
• Sponsor: University of Cologne
• Information provided by (Responsible Party): Prof. Dr. Andreas Engert, University of Cologne

Tracking Information

• First Submitted Date: August 10, 2007
• First Posted Date: August 13, 2007
• Last Update Posted Date: November 13, 2020
• Actual Study Start Date: May 2008
• Actual Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 11, 2008): Progression Free Survival [ Time Frame: 5 years ]
• Original Primary Outcome Measures (submitted: August 10, 2007): Progression Free Survival

Current Secondary Outcome Measures (submitted: July 28, 2010)

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

• Original Secondary Outcome Measures (submitted: August 10, 2007): Overall Survival acute and late toxicity CR-rate
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: HD18 for Advanced Stages in Hodgkins Lymphoma
• Official Title: Not Provided

Brief Summary

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: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hodgkins Lymphoma

Intervention

• Drug: Rituximab
  addition of Rituximab to BEACOPP escalated
• Drug: BEACOPP escalated
  chemotherapy with BEACOPP escalated

Study Arms

• Active Comparator: A
  8 cycles BEACOPPesc
  Intervention: Drug: BEACOPP escalated
• Experimental: B
  8 cycles BEACOPPesc plus rituximab
  Interventions:

  • Drug: Rituximab
  • Drug: BEACOPP escalated
• Active Comparator: C
  8 cycles BEACOPPesc
  Intervention: Drug: BEACOPP escalated
• Experimental: D
  4 cycles BEACOPPesc
  Intervention: Drug: BEACOPP escalated

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 15, 2008): 1500
• Original Enrollment: Not Provided
• Actual Study Completion Date: July 2020
• Actual Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00515554
• Other Study ID Numbers: HD18
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Prof. Dr. Andreas Engert, University of Cologne
• Original Responsible Party: Not Provided
• Current Study Sponsor: University of Cologne
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Andreas Engert, Prof.; University of Cologne

• PRS Account: University of Cologne
• Verification Date: November 2020