Back to resultsHD21 for Advanced Stages
Primary Purpose
Classical Hodgkin Lymphoma
Status
Recruiting
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Bleomycin
Etoposide
Doxorubicin
Cyclophosphamide
Vincristine
Procarbazine
Prednisone
Brentuximab Vedotin
Dacarbazine
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Classical Hodgkin Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Histologically proven classical Hodgkin lymphoma
- First diagnosis, no previous treatment, 18 to 60 years of age
- Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV
Exclusion Criteria:
- Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma
- Previous malignancy (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)
- Prior chemotherapy or radiotherapy
Sites / Locations
- University Hospital of CologneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
BEACOPP
BRECADD
Arm Description
4 or 6 cycles of BEACOPP (21-day cycles) Bleomycin (B) Etoposide (E) Doxorubicin (A) Cyclophosphamide (C) Vincristine (O) Procarbazin (P) Prednisone (P). If FDG-PET is negative after two cycles patients will be given a total of four cycles. If FDG-PET is positive after two cycles patients will bev given a total of six cycles.
4 or 6 cycles of BRECADD (21.day cycles) Brentuximab Vedotin (BR) Etoposide (E) Cyclophosphamide (C) Doxorubicin (A) Dacarbazine (D) Dexamethasone (D). If FDG-PET is negative after two cycles patients will be given a total of four cycles. If FDG-PET is positive after two cycles patients will be given a total of six cycles.
Outcomes
Primary Outcome Measures
Progression Free Survival
Treatment Related Morbidity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02661503
Brief Title
HD21 for Advanced Stages
Official Title
HD21 for Advanced Stages Treatment Optimization Trial in the First-line Treatment of Advanced Stage Hodgkin Lymphoma; Comparison of 6 Cycles of Escalated BEACOPP With 6 Cycles of BrECADD
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
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
Primary objective of the trial is to demonstrate non-inferior efficacy of six cycles of BrECADD compared to six cycles of escalated BEACOPP, each followed by radiotherapy to PET-positive residual lesions ≥2.5 cm, in terms of progression free survival (efficacy objective).
If non-inferior efficacy can be shown, the co-primary objective is to further demonstrate reduced toxicity of the BrECADD treatment compared to the escalated BEACOPP treatment measured by treatment related morbidity (TRMorbidity objective).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Classical Hodgkin Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BEACOPP
Arm Type
Active Comparator
Arm Description
4 or 6 cycles of BEACOPP (21-day cycles) Bleomycin (B) Etoposide (E) Doxorubicin (A) Cyclophosphamide (C) Vincristine (O) Procarbazin (P) Prednisone (P). If FDG-PET is negative after two cycles patients will be given a total of four cycles. If FDG-PET is positive after two cycles patients will bev given a total of six cycles.
Arm Title
BRECADD
Arm Type
Experimental
Arm Description
4 or 6 cycles of BRECADD (21.day cycles) Brentuximab Vedotin (BR) Etoposide (E) Cyclophosphamide (C) Doxorubicin (A) Dacarbazine (D) Dexamethasone (D). If FDG-PET is negative after two cycles patients will be given a total of four cycles. If FDG-PET is positive after two cycles patients will be given a total of six cycles.
Intervention Type
Drug
Intervention Name(s)
Bleomycin
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Type
Drug
Intervention Name(s)
Procarbazine
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Type
Drug
Intervention Name(s)
Brentuximab Vedotin
Intervention Type
Drug
Intervention Name(s)
Dacarbazine
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
5 years
Title
Treatment Related Morbidity
Time Frame
during 6 cycles of chemotherapy (21-day cycles)
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:
Histologically proven classical Hodgkin lymphoma
First diagnosis, no previous treatment, 18 to 60 years of age
Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV
Exclusion Criteria:
Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma
Previous malignancy (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)
Prior chemotherapy or radiotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Fuchs
Email
ghsg@uk-koeln.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Borchmann, Prof.
Organizational Affiliation
University of Cologne, I. Dept. of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Cologne
City
Cologne
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Borchmann, Prof.
12. IPD Sharing Statement
Learn more about this trial
HD21 for Advanced Stages
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