NCT06698003 · Memorial Sloan Kettering Cancer Center
A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1
What this study 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.
View original scientific description
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.
Interventions
DRUG
Mogamulizumab
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
Primary outcome measures
Minimum dose and schedule of mogamulizumab to reduce the proviral load by ≥75%
Time frame: 6 months from baseline
To define the minimum efficacious dose and schedule of mogamulizumab to reduce the proviral load by ≥75% by pre-emptive treatment of HTLV-1 carriers with a limited course of mogamulizumab. The minimum efficacious dose will maintain ≥75% reduction in PVL from baseline levels for a minimum 6 months post completion of preemptive treatment with a limited course of mogamulizumab.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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≥8% of PBMC)
- Age ≥18 years when informed consent is obtained
- Primary organ functions are stable
- Neutrophil count: ≥ 1000/mm3, unless patient has diagnosis of ethnic neutropenia
- Platelets: ≥100,000/mm3
- Hemoglobin: ≥9.0 g/dL
- Serum aspartate aminotransferase (AST): ≤1.5x upper limit of normal (ULN)
- Alanine aminotransferase (ALT): ≤1.5x ULN
- Total bilirubin: ≤1.5x ULN
Where
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2026 · Source of record for eligibility and locations