Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Hodgkin Lymphoma. (BREACH)
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|ClinicalTrials.gov Identifier: NCT02292979|
Recruitment Status : Active, not recruiting
First Posted : November 18, 2014
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma||Drug: Doxorubicin Drug: Bleomycin Drug: Vinblastine Drug: Dacarbazine Drug: Brentuximab Vedotin||Phase 2|
Patients will receive either ABVD chemotherapy (standard treatment = doxorubicin, bleomycin, vinblastine, dacarbazine) or the Brentuximab vedotin in combination with chemotherapy AVD (study treatment), depending on randomization. Radiotherapy is planned after chemotherapy or immunochemotherapy.
PET scans will be performed before inclusion, after 2 cycles of chemotherapy and after 4 cycles of chemotherapy (if PET after two cycles was positive), at the end of treatment and during follow-up period.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Stage I/II Unfavourable Hodgkin Lymphoma. A Randomized Phase II LYSA-FIL-EORTC Intergroup Study|
|Actual Study Start Date :||March 2015|
|Actual Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||August 2022|
Active Comparator: ABVD
Patients in standard arm receive Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine on Day 1 and D14 of each 4-week-cycle during 4 cycles
Patients in experimental arm receive Doxorubicin, Vinblastine, Dacarbazine and Brentuximab vedotin on Day 1 and D14 of each 4-week-cycle during 4 cycles
Drug: Brentuximab Vedotin
- PET2 assessment [ Time Frame: 8 weeks ]Assessment of PET after two cycles according to the five-point scale Deauville criteria (Negative = 1, 2, 3 and Positive = 4, 5), based on central review.
- Complete response (CR) rate [ Time Frame: 16 weeks ]according to Cheson 2007 criteria
- Progression free survival (PFS) [ Time Frame: 5 years ]Survival without disease progression
- Overall survival (OS) [ Time Frame: 5 years ]
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): NCT02292979
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|Principal Investigator:||Marc André, Pr||Lymphoma Study Association|
|Principal Investigator:||Luc Fornecker, Dr||Lymphoma Study Association|