Back to resultsHD17 for Intermediate Stage Hodgkin Lymphoma
Primary Purpose
Hodgkin Lymphoma
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)
ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)
30Gy IF-RT (Involved-Field Radiotherapy)
30Gy IN-RT (Involved-Node Radiotherapy)
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Hodgkin Lymphoma, intermediate stage, PET
Eligibility Criteria
Inclusion Criteria:
- Hodgkin Lymphoma
- CS I, II with risk factor (stage IIB with risk factor 1 or 2 are not included)
- large mediastinal mass (>1/3 of maximum transverse thorax diameter)
- extranodal involvement
- elevated ESR
- 3 or more involved nodal areas
- written informed consent
Exclusion Criteria:
- Leucocytes <3000/µl
- Platelets < 100000/µl
- Hodgkin Lymphoma as composite lymphoma
- Activity Index (WHO) >2
Sites / Locations
- 1st Dept. of Medicine, Cologne University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm A
Arm B
Arm Description
2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy
2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IN-RT if FDG-PET is positive after chemotherapy; 2 cycles BEACOPPescalated plus 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy
Outcomes
Primary Outcome Measures
Progression Free Survival
Secondary Outcome Measures
Overall Survival
CR rate
Rate of patients achieving a complete remission (CR/CRu) at final restaging after completion of study treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01356680
Brief Title
HD17 for Intermediate Stage Hodgkin Lymphoma
Official Title
HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 13, 2012 (Actual)
Primary Completion Date
March 21, 2020 (Actual)
Study Completion Date
March 23, 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 the non-inferiority of the experimental arm compared to the standard arm in terms of progression free survival (PFS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
Keywords
Hodgkin Lymphoma, intermediate stage, PET
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy
Arm Title
Arm B
Arm Type
Experimental
Arm Description
2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IN-RT if FDG-PET is positive after chemotherapy; 2 cycles BEACOPPescalated plus 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy
Intervention Type
Drug
Intervention Name(s)
BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)
Intervention Type
Drug
Intervention Name(s)
ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)
Intervention Type
Radiation
Intervention Name(s)
30Gy IF-RT (Involved-Field Radiotherapy)
Intervention Type
Radiation
Intervention Name(s)
30Gy IN-RT (Involved-Node Radiotherapy)
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
3 years
Title
CR rate
Description
Rate of patients achieving a complete remission (CR/CRu) at final restaging after completion of study treatment
Time Frame
6 months
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
CS I, II with risk factor (stage IIB with risk factor 1 or 2 are not included)
large mediastinal mass (>1/3 of maximum transverse thorax diameter)
extranodal involvement
elevated ESR
3 or more involved nodal areas
written informed consent
Exclusion Criteria:
Leucocytes <3000/µl
Platelets < 100000/µl
Hodgkin Lymphoma as composite lymphoma
Activity Index (WHO) >2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Engert, Prof.
Organizational Affiliation
University of Cologne, German Hodgkin Study Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Dept. of Medicine, Cologne University Hospital
City
Cologne
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
33539742
Citation
Borchmann P, Plutschow A, Kobe C, Greil R, Meissner J, Topp MS, Ostermann H, Dierlamm J, Mohm J, Thiemer J, Sokler M, Kerkhoff A, Ahlborn M, Halbsguth TV, Martin S, Keller U, Balabanov S, Pabst T, Vogelhuber M, Huttmann A, Wilhelm M, Zijlstra JM, Moccia A, Kuhnert G, Brockelmann PJ, von Tresckow B, Fuchs M, Klimm B, Rosenwald A, Eich H, Baues C, Marnitz S, Hallek M, Diehl V, Dietlein M, Engert A. PET-guided omission of radiotherapy in early-stage unfavourable Hodgkin lymphoma (GHSG HD17): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):223-234. doi: 10.1016/S1470-2045(20)30601-X.
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
Links:
URL
http://www.ghsg.org
Description
Homepage GHSG
Learn more about this trial
HD17 for Intermediate Stage Hodgkin Lymphoma
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