Actively Recruiting
A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-05
134
Participants Needed
7
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- Positive for anti-HTLV-1 antibody by approved tests
- High-risk phenotype with proviral load 8% or higher in blood cells
- Stable primary organ functions (neutrophils ≥1000/mm3 unless ethnic neutropenia, platelets ≥100,000/mm3, hemoglobin ≥9.0 g/dL, AST ≤1.5x ULN, ALT ≤1.5x ULN, bilirubin ≤1.5x ULN, creatinine ≤1.5x ULN, blood oxygen saturation ≥90%)
- Normal ECG with no abnormalities requiring treatment
- Written informed consent given
- For females and males of reproductive potential, use of effective contraception during and for 3 months after treatment
You will not qualify if you...
- Neutrophil count less than 1000/mm3 unless ethnic neutropenia
- Acute or chronic hepatitis or liver cirrhosis except certain antibody positive/PCR negative cases
- Active tuberculosis
- Heart attack within 12 months before enrollment
- Allergic reaction to antibody drugs
- Other cancers except certain localized and cured tumors
- Immunosuppressant or interferon alpha treatment within 6 months before enrollment
- Serious health complications like heart failure, lung, kidney, or liver failure, uncontrolled diabetes
- Active autoimmune disease requiring systemic treatment in past 2 years
- Any condition that could worsen with mogamulizumab
- Diagnosis of adult T-cell leukemia/lymphoma
- Pregnant, breastfeeding, or intending pregnancy during treatment or 3 months after
- Use of multivitamins or certain supplements within 2 weeks before enrollment
- Prior treatment with other study drugs within 4 months before consent
- Spinal cord compressive conditions such as cervical spine disease or disc herniation
- Uncontrolled psychiatric disorders, epilepsy, or dementia
- Positive tests for Hepatitis B surface antigen or HBV-DNA unless on prophylaxis
- Positive Hepatitis C antibody unless PCR negative
- Positive HIV antibody unless undetectable RNA for over 6 months and normal CD4
- Considered unqualified by study investigators
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (All protocol activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
S
Steven Horwitz, MD
CONTACT
A
Alison Moskowitz, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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