drugset / Trial / NCT01193842

Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas

NCT01193842 ↗

Phase 1/2 Completed 107 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This partially randomized phase I/II trial studies the side effects and the best dose of vorinostat when given together with combination chemotherapy and rituximab to see how well it works compared to combination chemotherapy alone in treating patients with human immunodeficiency virus-related diffuse large B-cell non-Hodgkin lymphoma or other aggressive B-cell lymphomas. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving vorinostat together with combination chemotherapy and rituximab may kill more cancer cells.

Timeline

Start
2010-10-06
Primary completion
2016-11-12
Completion
2022-05-19

Outcome

Missed primary endpoint

paper CR rates were 74% vs 68% for EPOCH vs EPOCH-vorinostat (P = .72). PMID 32430507 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified — Intravenous
Subject Etoposide Small molecule — Intravenous
Subject Vincristine Small molecule — Intravenous
Subject Vorinostat Small molecule 300 mg Oral
Background Cyclophosphamide Other / unclassified — Intravenous
Background Prednisone Other / unclassified — Oral
Background Rituximab Monoclonal antibody — Intravenous