Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Phase I and Pharmacokinetic Study of Ibrutinib in HIV-Infected Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Multiple Myeloma
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.
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.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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