Actively Recruiting
A Phase 2 Study for Screening and Prevention of Adult T-cell Leukemia/Lymphoma With Mogamulizumab in High-Risk Carriers of HTLV-1
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-05
134
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether the drug mogamulizumab can help prevent adult T-cell leukemia/lymphoma (ATL) in people at high risk due to infection with the HTLV-1 virus and immune cell changes. This phase 2 trial focuses on people infected with HTLV-1 who have a higher chance of developing ATL, aiming to see if mogamulizumab reduces the virus's presence in their blood. Participants are assigned to one of two treatment groups receiving mogamulizumab: Cohort 1 gets 0.3 mg/kg every 12 weeks for 2 doses, and Cohort 2 receives 0.3 mg/kg every 6 weeks for 4 doses. The study is non-randomized and unblinded, and treatments are given under medical supervision to evaluate dose effects on viral load reduction. During the study, participants undergo assessments including blood tests to measure the virus level, monitoring of organ function, and safety checks like electrocardiograms. Researchers will primarily measure how much the viral load decreases six months after starting treatment. The study lasts through the treatment period and follow-up, with careful observation to understand mogamulizumab's impact on preventing ATL development.
CONDITIONS
Brief 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 the time of informed consent
- Written informed consent provided
- Positive for anti-HTLV-1 antibody using approved assays
- High-risk phenotype with proviral load of 8% or more in peripheral blood mononuclear cells
- Stable primary organ functions including neutrophil count ≥1000/mm3 (except ethnic neutropenia), platelets ≥100,000/mm3, hemoglobin ≥9.0 g/dL
- Liver and kidney function tests within 1.5 times the upper limit of normal
- Blood oxygen saturation ≥90%
- Normal electrocardiogram with no treatment-requiring abnormalities
- For females of reproductive potential, use effective contraception during treatment and for at least 3 months after last dose; same for males with female partners
You will not qualify if you...
- Neutrophil count less than 1000/mm3 (unless ethnic neutropenia)
- History of acute or chronic hepatitis or hepatic cirrhosis (except certain antibody-positive, PCR-negative cases)
- Active or history of tuberculosis
- Myocardial infarction within 12 months before enrollment
- Allergic reaction to antibody drug products
- History of other cancers unless cured and disease-free as specified
- Immunosuppressant or interferon alpha treatment within 6 months prior to enrollment
- Serious complications including heart failure, lung disease, renal or hepatic failure, uncontrolled diabetes
- Active autoimmune disease requiring systemic treatment within past 2 years
- Diagnosis of adult T-cell leukemia/lymphoma
- Pregnancy, breastfeeding, or planning pregnancy during or within 3 months of last drug dose
- Use of certain supplements or multivitamins within 2 weeks before enrollment
- Prior treatment with other study drugs within 4 months before consent
- Spinal cord compression complications
- Uncontrolled psychiatric illness, epilepsy, or dementia
- Positive for Hepatitis B surface antigen or HBV-DNA unless on prophylaxis
- Positive for Hepatitis C antibody unless PCR negative
- Positive for HIV antibody unless undetectable RNA >6 months and normal CD4
- Any condition judged by investigators to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks depending on cohort assignment
Participants receive mogamulizumab according to their assigned cohort schedule.
2 doses every 12 weeks for Cohort 1; 4 doses every 6 weeks for Cohort 2
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
A
Alison Moskowitz, MD
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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