Nivolumab in Treating Patients With HTLV-Associated T-Cell Leukemia/Lymphoma
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|ClinicalTrials.gov Identifier: NCT02631746|
Recruitment Status : Active, not recruiting
First Posted : December 16, 2015
Last Update Posted : May 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Adult T-Cell Leukemia/Lymphoma Adult T-Cell Leukemia/Lymphoma CD3 Positive CD4-Positive Neoplastic Cells Present Chronic Adult T-Cell Leukemia/Lymphoma HTLV-1 Infection Hypercalcemia Lymphomatous Adult T-Cell Leukemia/Lymphoma Recurrent Adult T-Cell Leukemia/Lymphoma Smoldering Adult T-Cell Leukemia/Lymphoma||Other: Laboratory Biomarker Analysis Biological: Nivolumab Other: Pharmacogenomic Study||Phase 2|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Nivolumab for HTLV-Associated Adult T Cell Leukemia/Lymphoma|
|Actual Study Start Date :||June 3, 2016|
|Actual Primary Completion Date :||November 30, 2017|
|Estimated Study Completion Date :||November 30, 2018|
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.
Other: Laboratory Biomarker Analysis
Other: Pharmacogenomic Study
Other Name: PHARMACOGENOMIC
- 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.
- Duration of response [ Time Frame: From the time measurement criteria are met for complete response (CR) or partial response (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.
- Effects of treatment [ Time Frame: Up to 1 year ]Analysis of variance methods will be used to evaluate the effects of treatment.
- 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.
- HTLV-1 clonality [ Time Frame: Up to 1 year ]Measured from peripheral blood mononuclear cell (PBMC) samples.
- HTLV-1 specific cytotoxic T lymphocytes (CTLs) [ Time Frame: Up to 1 year ]Measured from PBMC samples.
- Immune cell numbers [ Time Frame: Up to 1 year ]Measured from blood and tissue samples.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631746
|United States, Maryland|
|Johns Hopkins University/Sidney Kimmel Cancer Center|
|Baltimore, Maryland, United States, 21287|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|NCI - Center for Cancer Research|
|Bethesda, Maryland, United States, 20892|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Montefiore Medical Center-Einstein Campus|
|Bronx, New York, United States, 10461|
|Montefiore Medical Center - Moses Campus|
|Bronx, New York, United States, 10467|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Lee Ratner||Duke University - Duke Cancer Institute LAO|