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HD18 for Advanced Stages in Hodgkins Lymphoma

Primary Purpose

Hodgkins Lymphoma

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Rituximab
BEACOPP escalated
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkins Lymphoma focused on measuring Hodgkin lymphoma, PET, advances stages, Rituximab

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1st Dept. of Medicine, Cologne University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

A

B

C

D

Arm Description

8 cycles BEACOPPesc

8 cycles BEACOPPesc plus rituximab

8 cycles BEACOPPesc

4 cycles BEACOPPesc

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

Overall Survival
acute toxicity
late toxicity
CR-rate

Full Information

First Posted
August 10, 2007
Last Updated
November 11, 2020
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT00515554
Brief Title
HD18 for Advanced Stages in Hodgkins Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 2008 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkins Lymphoma
Keywords
Hodgkin lymphoma, PET, advances stages, Rituximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
8 cycles BEACOPPesc
Arm Title
B
Arm Type
Experimental
Arm Description
8 cycles BEACOPPesc plus rituximab
Arm Title
C
Arm Type
Active Comparator
Arm Description
8 cycles BEACOPPesc
Arm Title
D
Arm Type
Experimental
Arm Description
4 cycles BEACOPPesc
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
addition of Rituximab to BEACOPP escalated
Intervention Type
Drug
Intervention Name(s)
BEACOPP escalated
Intervention Description
chemotherapy with BEACOPP escalated
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
5 years
Title
acute toxicity
Time Frame
5 years
Title
late toxicity
Time Frame
5 years
Title
CR-rate
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Engert, Prof.
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Dept. of Medicine, Cologne University Hospital
City
Cologne
ZIP/Postal Code
50924
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
34048679
Citation
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.
Results Reference
derived
PubMed Identifier
30166329
Citation
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.
Results Reference
derived
PubMed Identifier
30010775
Citation
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.
Results Reference
derived
PubMed Identifier
29061295
Citation
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.
Results Reference
derived
PubMed Identifier
28236583
Citation
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.
Results Reference
derived
PubMed Identifier
23225085
Citation
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.
Results Reference
derived

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HD18 for Advanced Stages in Hodgkins Lymphoma

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