Study Title
Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Hodgkin Lymphoma. (BREACH)(NCT02292979)
Trial Description
This study aims to evaluate the efficacy of brentuximab vedotin + AVD combination (doxorubicine, vinblastine, dacarbazine) in patients with Hodgkin lymphoma stage I / II with an unfavorable diagnosis, assessed by the negativity of PET (positron emission tomography) after two cycles of chemotherapy.
The BREACH (also known as LYSA/FIL/EORTC-20113) study in early stage HL patients, incorporating the anti -CD30 conjugate brentuximab vedotin in first-line treatment of unfavorable CSI/II disease (AVD-Br vs ABVD, followed by involved node radiotherapy or INRT). The primary goal is to improve the PET negativity after two cycles of chemotherapy. Next to the more common secondary end points (PFS, OS, CR rate after 2 cycles), researchers are very interested in the toxicity pattern of brentuximab vedotin in combination therapy.
This trial is sponsored by The Lymphoma Academic Research Organization (LYSARC) [1]
Study Data
- Condition: Hodgkin Lymphoma
- Interventions:
- Drugs used in this trial
- Doxorubicin (Adriamycin®; Pfizer/Doxil®; TTY Bio pharmacy Company Limited)
- Bleomycin (Generic; Teva Parenteral Medicines, Inc.)
- Vinblastine (Generic; APP Pharmaceuticals, LLC)
- Dacarbazine (DTIC-Dome®; Bayer Pharmaceuticals Corporation)
- Brentuximab vedotin (Adcetris®; Seattle Genetics, Inc.)
- Drugs used in this trial
- Phase: II
- Estimated Enrollment: 170
- Start: March 2015
- Estimated Completion: August 2022
- Last verified: March 2015
Study Schematic
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Last Editorial review: July 15, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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