Mogamulizumab for Preventing Adult T-cell Leukemia/Lymphoma in People with HTLV-1
This study is testing if a drug called mogamulizumab can help prevent adult T-cell leukemia/lymphoma (ATL) in people who have the HTLV-1 virus. People with HTLV-1 are at a higher risk for ATL, especially if they have certain changes in their immune system cells (T-cells). The study will look at different doses and schedules of mogamulizumab to see which one best reduces the amount of HTLV-1 virus in the body. To join, you must be at least 18 years old and have a positive test for the HTLV-1 antibody. The study aims to enroll 134 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 134 participants into different groups receiving mogamulizumab at varying doses and schedules.
- What's involved
- Participants in the treatment groups will receive either two doses of mogamulizumab every 12 weeks or four doses every 6 weeks. The study will measure how much the HTLV-1 virus in your body changes over 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal of the study is measured at 6 months from when you start treatment.
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NCT06698003
A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1
Recruiting
PHASE2Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~134 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:Mogamulizumab
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Minimum dose and schedule of mogamulizumab to reduce the proviral load by ≥75%
Measured over 6 months from baseline
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Steven Horwitz, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Age ≥18 years when informed consent is obtained
Has freely given written informed consent to participate in the study
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
Serum creatinine (Cr): ≤1.5x ULN
Blood oxygen saturation (SpO2): ≥90%
Electrocardiogram (ECG): No abnormal findings requiring treatment are observed
Has freely given written informed consent to participate in the study
For females of reproductive potential: use of effective contraception during treatment and for at least 3 months after completion of mogamulizumab therapy. For males who have sexual intercourse with females of reproductive potential: use of effective contraception during treatment and for at least 3 months after completion of mogamulizumab therapy.
Exclusion
Patients with a history of any of the following:
Neutrophil count: ≤1000/mm3, unless patient has diagnosis of ethnic neutropenia
Acute or chronic hepatitis or hepatic cirrhosis, other than patients with positive antibodies and negative PCR as noted in criteria #11 and #12 below.
Tuberculosis or with active tuberculosis
Myocardial infarction within 12 months prior to the date of enrollment
Allergic reaction to administration of antibody drug products
Other cancers. Patients with a history of a localized solid tumor who received definitive, curative treatment and who have been without evidence of disease for 5 years prior to enrollment will be able to enroll in the study. Patients with radically resected basal cell carcinoma of the skin, squamous cell carcinoma (except malignant melanoma), noninvasive cervix carcinoma, carcinoma in situ in the gastrointestinal tract or corpus of the uterus, localized thyroid cancer, and localized renal cell carcinoma will be able to enroll in the study if they are determined to be completely cured, even if within 5 years of enrollment.
Prior treatment with immunosuppressants or interferon alpha products within 6 months prior to the date of enrollment
Serious complications (heart failure, lung disease, renal failure, hepatic failure, uncontrolled diabetes mellitus, etc.)
History of an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
Any ailment that could be exacerbated by the administration of KW-0761, in the judgment of the Principal Investigator or co-Investigator
Diagnosis of ATL
Women who are pregnant, breastfeeding, who may be pregnant, or wish to bear children while receiving treatment or within 3 months of last dose of mogamulizumab
Patients who have taken multivitamins (Alinamin, vitamin C, etc.) or supplements such as fucoidan, catechin, and pentosan polysulfate within 2 weeks prior to the date of enrollment
Prior treatment with other study drugs within 4 months prior to giving informed consent
Complications of spinal cord compressive lesions such as cervical spine disease, disc herniation, and ossification of the yellow ligament
Uncontrolled psychiatric disorder, epilepsy, or dementia
Positive test for Hepatitis B surface antigen or HBV-DNA (using real-time PCR). Positive Hepatitis B core antibody is permitted if HBV-DNA PCR is negative and the patient remains on prophylaxis during study.
Positive test for Hepatitis C virus antibody, unless Hepatitis C PCR is negative.
Positive test for HIV antibody, unless undetectable HIV RNA \> 6 months and CD4 within normal limits per institutional standard.
Patients considered unqualified to participate in the study by the Principal Investigator or co-Investigator
What this trial measures
- Minimum dose and schedule of mogamulizumab to reduce the proviral load by ≥75%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.