drugset / Trial / NCT01479842

Rituxan/Bendamustine/PCI-32765 in Relapsed DLBCL, MCL, or Indolent Non-Hodgkin's Lymphoma

NCT01479842

Phase 1 Active not recruiting 48 enrolled Kami Maddocks, MD Pharmacyclics LLC. · collab
NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and best dose of BTK inhibitor PCI-32765 when given together with rituximab and bendamustine hydrochloride in treating patients with recurrent non-Hodgkin lymphoma (NHL). BTK inhibitor PCI-32765 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving BTK inhibitor PCI-32765 together with rituximab and bendamustine hydrochloride may kill more cancer cells.

Timeline

Start
2014-03-26
Primary completion
2026-07-01
Completion
2026-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibrutinib Small molecule 280 mg Oral
Subject Ibrutinib Small molecule 560 mg Oral
Background Bendamustine Small molecule 90 mg/m2 Intravenous
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous