HD21 for Advanced Stages
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|ClinicalTrials.gov Identifier: NCT02661503|
Recruitment Status : Recruiting
First Posted : January 22, 2016
Last Update Posted : October 29, 2018
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|
|Classical Hodgkin Lymphoma||Drug: Bleomycin Drug: Etoposide Drug: Doxorubicin Drug: Cyclophosphamide Drug: Vincristine Drug: Procarbazine Drug: Prednisone Drug: Brentuximab Vedotin Drug: Dacarbazine Drug: Dexamethasone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||July 2016|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||September 2025|
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.
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: Brentuximab Vedotin
- Progression Free Survival [ Time Frame: 5 years ]
- Treatment Related Morbidity [ Time Frame: during 6 cycles of chemotherapy (21-day cycles) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661503
|Contact: Michael Fuchsemail@example.com|
|University Hospital of Cologne||Recruiting|
|Contact: Peter Borchmann, Prof.|
|Principal Investigator:||Peter Borchmann, Prof.||University of Cologne, I. Dept. of Medicine|