RECRUITING

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

Conditions

T-Cell Leukemia/Lymphoma, Adult T-cell Leukemia/Lymphoma T-cell Leukemia Lymphoma Mogamulizumab HTLV-1 Memorial Sloan Kettering Cancer Center 21-486

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-11-15

Study Completion:2029-11-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06698003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 (Avioq HTLV-I/II Microelisa System) * 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.	* 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

Inclusion Criteria

Exclusion Criteria

* 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 (Avioq HTLV-I/II Microelisa System)
* 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.

* 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

Contacts and Locations

Study Contact

Steven Horwitz, MD

CONTACT

646-608-2680

horwitzs@MSKCC.ORG

Alison Moskowitz, MD

CONTACT

646-608-3726

moskowia@mskcc.org

Principal Investigator

Steven Horwitz, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering at Basking Ridge (All protocol activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645

United States

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

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (All protocol activities)

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Steven Horwitz, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-15

Study Completion Date2029-11-15

Study Record Updates

Study Start Date2024-11-15

Study Completion Date2029-11-15

Terms related to this study

Keywords Provided by Researchers

T-Cell Leukemia/Lymphoma, Adult
T-cell Leukemia/Lymphoma
T-cell leukemia
Lymphoma
Mogamulizumab
HTLV-1
Memorial Sloan Kettering Cancer Center
21-486

Additional Relevant MeSH Terms

T-Cell Leukemia/Lymphoma, Adult
T-cell Leukemia/Lymphoma
T-cell Leukemia
Lymphoma