BV-AVD in Patients With Newly-Diagnosed, Early Stage, Bulky Hodgkin Lymphoma Using a PET-adapted and MTV-guided Approach
Summary
The purpose of this study is to test whether BV-AVD is an effective treatment in people with early stage, bulky Hodgkin lymphoma that was recently diagnosed and who have not yet received any treatments for their disease. BV is a type of drug called an antibody-drug conjugate (ADC). ADCs are a substance made up of a monoclonal antibody chemically linked to a drug. Antibodies are proteins made by the immune system to fight infections and other possible harms to the body. The monoclonal antibody binds to specific proteins or receptors found on certain types of cells, including cancer cells. The linked drug enters these cells and kills them without harming other cells. Researchers think BV may be an effective treatment for this type of cancer because the drug targets cells that have CD30, which play a role in cancer cell growth. By destroying these cells, BV may help slow or stop the growth of the cancer. AVD (doxorubicin, vinblastine, and dacarbazine) is a treatment regimen that works by stopping the growth of cancer cells, either by killing the cells or by stopping them from dividing. The researchers think that BV in combination with AVD may work better than AVD alone to slow or stop the growth of the cancer.
Arms & interventions
- DrugBrentuximab vedotin
Brentuximab vedotin will be administered at 1.2 mg/kg IV on days 1 and 15 of each 28-day cycle
- DrugDoxorubicin
Doxorubicin 25 mg/m\^2 IV
- DrugVinblastine
Vinblastine 6 mg/m\^2 IV
- DrugDacarbazine
Dacarbazine 375 mg/m\^2 IV on days 1 and 15 of each 28-day cycle
- DrugPembrolizumab
Pembrolizumab will be administered at 200 mg IV (flat) on day 1
- DrugGemcitabine
Gemcitabine 1000 mg/m\^2 IV (days 1 an
- DrugVinorelbine
Vinblastine 6 mg/m\^2 IV
- Diagnostic TestFDG-PET/CT scan
After 2 cycles of therapy, patients will undergo FDG-PET/CT scan
Outcome measures
Primary
progression-free survival
Time frame: 3 years
Secondary
overall survival
Time frame: 3 years
Eligibility criteria
Study locations (8)
University of Miami
Miami, Florida, 33136
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553