Clinical Trials Directory

Trials / Terminated

TerminatedNCT02109224

Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection

Phase I and Pharmacokinetic Study of Ibrutinib in HIV-Infected Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Multiple Myeloma

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
72 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I trial studies the side effects and best dose of ibrutinib in treating B-cell non-Hodgkin lymphoma that has returned or does not respond to treatment in patients with human immunodeficiency virus (HIV) infection. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether it is safe for patients with HIV infection to receive ibrutinib while also taking anti-HIV drugs.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of single-agent ibrutinib in combination with antiretroviral therapy (ART) specifically with respect to ibrutinib metabolism in HIV-infected patients with relapsed or refractory B-cell neoplasms. II. To determine the maximum tolerated dose (MTD) of ibrutinib in this setting. SECONDARY OBJECTIVES: I. To characterize ibrutinib pharmacokinetics in relation to ART-cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) interactions. II. To describe toxicity in relation to plasma concentrations of ibrutinib and its main metabolite. III. To estimate objective response rate, clinical benefit, times to tumor response and progression, and 6-month and 1-year progression-free and overall survival. IV. To describe changes in HIV viral load, immunologic parameters, and Epstein-Barr virus (EBV) and human herpesvirus 8 (HHV-8) deoxyribonucleic acid (DNA) copy numbers in plasma and in peripheral blood mononuclear cells (PBMC) in relation to ibrutinib therapy. OUTLINE: This is a dose-escalation study. Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.

Conditions

Interventions

TypeNameDescription
DRUGIbrutinibGiven PO
OTHERLaboratory Biomarker AnalysisCorrelative studies
OTHERPharmacological StudyCorrelative studies

Timeline

Start date
2014-09-01
Primary completion
2015-07-01
Completion
2015-07-01
First posted
2014-04-09
Last updated
2015-08-20

Locations

7 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02109224. Inclusion in this directory is not an endorsement.