AIDS Malignancy Consortium 101: A Pilot Study to Assess Adding Ibrutinib to Standard R-EPOCH Treatment for AIDS-Related Lymphomas

Full Title

AMC101: A Pilot Study of Ibrutinib and R-da-EPOCH for Front Line Treatment of AIDS-Related Lymphomas

Purpose

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).

Eligibility

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.

Protocol

17-543

Phase

I

Investigator

Co-Investigators