A Phase 2 Study for Screening and Prevention of Adult T-cell Leukemia/Lymphoma With Mogamulizumab in High-Risk Carriers of HTLV-1
Memorial Sloan Kettering Cancer Center
Summary
The purpose of this study is to find out whether the study drug mogamulizumab is effective in preventing the development of adult T-cell leukemia/lymphoma (ATL) in people who are at higher risk for this type of cancer because they are infected with the HTLV-1 virus and because of changes seen in some of their immune system cells called T-cells.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Screening Cohort (US patients only): * Age ≥18 years when informed consent is obtained * Has freely given written informed consent to participate in the study Treatment Cohorts (Cohorts 1 and 2): * Positive for anti-HTLV-1 antibody in the serum using an FDA approved assay for US patients (Avioq HTLV-I/II Microelisa System). UK patients should use UK Accreditation Service (UKAS) accredited tests, Abbot Architect ELISA Serology Screening assay and confirmatory serology Western Blot (performed at Public Health England, Virus Ref Dept, Colindale). * High-risk phenotype (PVL…
Interventions
- DrugMogamulizumab
Cohort 1: 0.3 mg/kg of mogamulizumab every 12 weeks, for 2 total doses Cohort 2: 0.3 mg/kg of mogamulizumab every 6 weeks, for 4 total doses
Locations (7)
- Memorial Sloan Kettering at Basking Ridge (All protocol activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (All protocol activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (All Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities)Commack, New York
- Memorial Sloan Kettering Westchester (All protocol activities)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York