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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02631746
Phase
PHASE2
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV
  • Pharmacogenomic Study — OTHER
    Correlative studies

Study Details

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.

Key Dates

Start date
Feb 23, 2017
Status verified
Mar 2025
Primary completion
Mar 30, 2018
Completion
Jul 31, 2019

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nivolumab)
    Patients receive nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 46 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of Adverse Events of Nivolumab, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [ Time Frame: 1 year ]

Locations (6)

FacilityCityStateZIPSite coordinators
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
NCI - Center for Cancer ResearchBethesdaMaryland20892-
Montefiore Medical Center - Moses CampusThe BronxNew York10467-
Montefiore Medical Center-Einstein CampusThe BronxNew York10461-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDNational Institutes of Health Clinical Center· Bethesda, MDNCI - Center for Cancer Research· Bethesda, MDMontefiore Medical Center - Moses Campus· The Bronx, NYMontefiore Medical Center-Einstein Campus· The Bronx, NYOhio State University Comprehensive Cancer Center· Columbus, OH

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