CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Rituximab +1 moredrug
Likely dose
Rituximab 375 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01520519
NCT01520519Phase 2Completed
CompareCT.gov

A Phase 2 Study of the Combination of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 and Rituximab in High-Risk Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) Patients

M.D. Anderson Cancer Center·interventional·Posted Jan 30, 2012·Updated Sep 18, 2019

In Brief

A Phase 2 clinical trial evaluating Rituximab and PCI-32765 for Leukemia. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if PCI-32765 (Ibrutinib) combined with rituximab can help to control CLL and SLL. The safety of this combination will also be studied. Ibrutinib is designed to stop a protein from working in the cells, which may cause the cancer cells to die or stop growing. Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to die.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States
CollaboratorsPharmacyclics LLC.

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 30, 2012
Enrollment StartFeb 27, 2012
Primary CompletionAug 9, 2018
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 14.4 years ago

Interventions

Rituximabdrug

375 mg/m2 intravenously on Day 1, Day 8, Day 15, and Day 22, then continued once every 4 weeks only on Days 1 during cycles 2 - 6.

PCI-32765drug

420 mg (3 \* 140-mg capsules) orally started on Day 2 of cycle 1 once daily and will be continued daily.