NCT02631746

Nivolumab in Treating Patients With HTLV-Associated T-Cell Leukemia/Lymphoma

Phase II Trial of Nivolumab for HTLV-Associated Adult T Cell Leukemia/Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well nivolumab works in treating patients with human T-cell leukemia virus (HTLV)-associated T-cell leukemia/lymphoma. Nivolumab is an antibody, which is a type of blood protein that tags infected cells and other harmful agents. Nivolumab works against a protein called programmed cell death (PD)-1 and may help the body destroy cancer cells by helping the immune system to keep fighting cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety and tolerability of nivolumab for patients with HTLV-associated adult T-cell leukemia lymphoma (ATLL). II. To determine the efficacy of nivolumab for patients with HTLV-associated ATLL. SECONDARY OBJECTIVES: I. To determine effects of nivolumab on HTLV-1 proviral deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) loads. II. To determine the effects of nivolumab on anti-HTLV-1 and anti-ATLL immune responses. III. To determine effects of nivolumab on HTLV-1 integration site clonality. OUTLINE: Patients receive nivolumab intravenously (IV) over 60 minutes on day 1. Treatment repeats every 14 days for 46 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year.

Conditions

• Acute Adult T-Cell Leukemia/Lymphoma
• Adult T-Cell Leukemia/Lymphoma
• Chronic Adult T-Cell Leukemia/Lymphoma
• HTLV-1 Infection
• Lymphomatous Adult T-Cell Leukemia/Lymphoma
• Smoldering Adult T-Cell Leukemia/Lymphoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Nivolumab	Given IV
OTHER	Pharmacogenomic Study	Correlative studies

Timeline

• Start date: 2017-02-23
• Primary completion: 2018-03-30
• Completion: 2019-07-31
• First posted: 2015-12-16
• Last updated: 2025-03-14
• Results posted: 2019-03-01

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study