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Preventing Adult T-cell Leukemia/Lymphoma in People with HTLV-1

A Phase 2 Study for Screening and Prevention of Adult T-cell Leukemia/Lymphoma With Mogamulizumab in High-Risk Carriers of HTLV-1

Phase 2 Interventional Memorial Sloan Kettering Cancer Center · NCT06698003

This study is testing if a new drug called mogamulizumab can help prevent adult T-cell leukemia/lymphoma in adults who are infected with the HTLV-1 virus and are at higher risk for this cancer.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment134 (estimated)
Ages18 Years and up
SexAll
SponsorMemorial Sloan Kettering Cancer Center Academic / other
Drugs / interventionsmogamulizumab
Locations7 sites (Basking Ridge, New Jersey and 6 other locations)
Trial IDNCT06698003 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of mogamulizumab in preventing adult T-cell leukemia/lymphoma (ATL) in individuals infected with the HTLV-1 virus who are at higher risk for developing this cancer. Participants must be at least 18 years old and provide informed consent. The study focuses on patients with a specific high-risk phenotype characterized by a certain percentage of infected T-cells. The trial is conducted at multiple locations affiliated with Memorial Sloan Kettering Cancer Center.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are HTLV-1 positive and exhibit a high-risk phenotype.

Not a fit: Patients who are not infected with HTLV-1 or do not meet the high-risk criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a preventive treatment option for individuals at high risk of developing ATL due to HTLV-1 infection.

How similar studies have performed: While this approach is novel in the context of ATL prevention, similar studies targeting other cancers have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
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
  * 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 Criteria:

In order to protect subjects and avoid any problems in evaluating the study drug, patients who meet any of the following criteria should be excluded from enrollment in the study, in either screening or treatment cohorts:

* 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

Where this trial is running

Basking Ridge, New Jersey and 6 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions T-Cell Leukemia/Lymphoma, AdultT-cell Leukemia/LymphomaT-cell LeukemiaLymphomaT-cell leukemiaMogamulizumabHTLV-1Memorial Sloan Kettering Cancer Center
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.