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A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1 | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Study of Mogamulizumab to Prevent 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

NCT06698003•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+9 more criteria

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.)
+12 more criteria

Locations (7)

Memorial Sloan Kettering at Basking Ridge (All protocol activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (All protocol activities)

Uniondale, New York, United States

Key Dates

Start Date

November 15, 2024

Primary Completion Date

November 15, 2029

Completion Date

November 15, 2029

Last Updated

March 5, 2026

Enrollment

134

ESTIMATED participants

Conditions

T-Cell Leukemia/Lymphoma, AdultT-cell Leukemia/LymphomaT-cell LeukemiaLymphoma

Interventions

Mogamulizumab

DRUG

Contacts

Steven Horwitz, MD

CONTACT

646-608-2680 horwitzs@MSKCC.ORG

Alison Moskowitz, MD

CONTACT

646-608-3726 moskowia@mskcc.org

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

NCT07388563

Lymphoma, T Cell, PeripheralT-cell Lymphoma+4 more

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Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma

NCT07356245

T-cell LymphomaGraft Versus Host Disease+6 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1

Inclusion Criteria

Exclusion Criteria

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