Full Title
AMC101: A Pilot Study of Ibrutinib and R-da-EPOCH for Front Line Treatment of AIDS-Related LymphomasPurpose
This study is being done to develop better treatments for B-cell non-Hodgkin lymphoma for HIV-positive people. The purpose of this study is to test the safety and effectiveness of the drug ibrutinib when added to the standard lymphoma treatment (R-da-EPOCH). Researchers believe that adding ibrutinib may improve the effectiveness of R-da-EPOCH for treating AIDS-related lymphomas. Researchers will also study whether ibrutinib has a helpful effect against HIV and other viruses that can cause lymphoma.
Ibrutinib works by blocking a protein inside lymphoma cells called Bruton’s tyrosine kinase (BTK), which helps lymphoma cells to live and grow. It is taken by mouth; other drugs used in this study are given intravenously (by vein).
Who Can Join
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have stage II-IV diffuse large B-cell lymphoma and be positive for HIV.
- Patients in the part of the study looking at ibrutinib dose may not have previously received treatment; patients in the dose-expansion part of the study (looking at treatment effectiveness) may have had one prior cycle of combination chemotherapy (R-EPOCH or R-CHOP) up to 3-4 weeks before entering this study.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for patients age 18 and older.
For more information about this study and to inquire about eligibility, please contact Dr. Ariela Noy at 212-639-7423.