Clinical Trial: Nivolumab in Treating Patients With HTLV-Associated T-Cell Leukemia/Lymphoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Phase II Trial of Nivolumab for HTLV-Associated Adult T Cell Leukemia/Lymphoma
Brief 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 Summary:
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 60-120 minutes on day 1. Treatment repeats every 2 weeks 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.
Sponsor: National Cancer Institute (NCI)
Current Primary Outcome:
- Duration of response [ Time Frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 1 year ]Summarized using descriptive statistics. Binomial proportions and their 90% confidence intervals will be used to estimate the response rates of therapy. The Kaplan-Meier method will be used to evaluate the response duration.
- Incidence of adverse events of nivolumab, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 1 year ]Toxicity by grade will be summarized using descriptive statistics. The incidence of toxicities will be estimated using the binomial proportion and its 90% confidence interval.
- Tumor response, evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors guideline (version 1.1) [ Time Frame: Up to 1 year ]Summarized using descriptive statistics. Binomial proportions and their 90% confidence intervals will be used to estimate the response rates of therapy.
Original Primary Outcome: Incidence of adverse events of nivolumab, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 1 year ]
Current Secondary Outcome:
- Effects of treatment [ Time Frame: Up to 1 year ]Analysis of variance methods will be used to evaluate the effects of treatment.
- HTLV-1 clonality [ Time Frame: Up to 1 year ]
- HTLV-1 specific CT's [ Time Frame: Up to 1 year ]
- Immune cell numbers [ Time Frame: Up to 1 years ]
- Time on the viral load measurements [ Time Frame: Up to 1 year ]Analysis of variance methods will be used to evaluate the effects of treatment and time on the viral load measurements, as well as measurements of viral transcripts. A proportional hazards analysis with viral load measures as time dependent covariates will be used to evaluate the effects of these measures on duration of response.
Original Secondary Outcome:
- Duration of response [ Time Frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 1 year ]Summarized using descriptive statistics. Binomial proportions and their 90% confidence intervals will be used to estimate the response rates of therapy. The Kaplan-Meier method will be used to evaluate the response duration.
- Length of follow-up [ Time Frame: Up to 1 year ]Summarized using descriptive statistics.
- Time on the viral load measurements [ Time Frame: Up to 1 year ]Analysis of variance methods will be used to evaluate the effects of treatment and time on the viral load measurements, as well as measurements of viral transcripts. A proportional hazards analysis with viral load measures as time dependent covariates will be used to evaluate the effects of these measures on duration of response.
- Tumor response, evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors guideline (version 1.1) [ Time Frame: Up to 1 year ]Summarized using descriptive statistics. Binomial proportions and their 90% confidence intervals will be used to estimate the response rates of therapy.
Information By: National Cancer Institute (NCI)
Dates:
Date Received: December 15, 2015
Date Started: June 2016
Date Completion:
Last Updated: May 19, 2017
Last Verified: May 2017