HD21 for Advanced Stages
Study Details
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: BEACOPP 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. |
Drug: Bleomycin
Drug: Etoposide
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Procarbazine
Drug: Prednisone
|
Experimental: BRECADD 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. |
Drug: Etoposide
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Brentuximab Vedotin
Drug: Dacarbazine
Drug: Dexamethasone
|
Outcome Measures
Primary Outcome Measures
- Progression Free Survival [5 years]
- Treatment Related Morbidity [during 6 cycles of chemotherapy (21-day cycles)]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically proven classical Hodgkin lymphoma
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First diagnosis, no previous treatment, 18 to 60 years of age
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Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV
Exclusion Criteria:
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Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma
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Previous malignancy (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)
-
Prior chemotherapy or radiotherapy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University Hospital of Cologne | Cologne | Germany |
Sponsors and Collaborators
- University of Cologne
Investigators
- Principal Investigator: Peter Borchmann, Prof., University of Cologne, I. Dept. of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Uni-Koeln-1762
- 2014-005130-55