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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether mogamulizumab can prevent adult T-cell leukemia/lymphoma (ATL), a cancer of immune cells. It is for adults with HTLV-1 who have a higher risk of this cancer because of changes in their T-cells, a type of immune cell.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- For the screening group, which is only for US patients: be at least 18 and freely sign a written consent form.
- For the treatment groups: be at least 18 and freely sign a written consent form.
- For treatment: have a positive HTLV-1 antibody blood test using an approved test.
- For treatment: have a high HTLV-1 level in certain blood cells, meeting the study's cutoff of at least 8%.
- For treatment: have stable organ function and meet the study's blood count, liver, kidney, and blood oxygen limits.
- For treatment: have no heart tracing test (ECG) findings that need treatment.
- For treatment: use effective birth control during treatment and for at least 3 months afterward if you can become pregnant or have sex with a woman who can become pregnant.
Who can't join
- Already have ATL, or have a history of other cancer. Some fully treated and cured cancers are allowed.
- Have a history of very low infection-fighting white blood cells, tuberculosis, liver inflammation or scarring, an allergic reaction to antibody drugs, or a heart attack in the past 12 months. Some low blood count and liver infection exceptions apply.
- Have serious health problems, such as heart, lung, kidney, or liver failure or uncontrolled diabetes; pressure on the spinal cord; or an uncontrolled mental health disorder, epilepsy, or dementia.
- Have an autoimmune disease, where the body attacks itself, that needed whole-body treatment in the past 2 years. Hormone replacement treatment is allowed.
- Used drugs that weaken the immune system or interferon alpha in the past 6 months; another study drug within 4 months before consent; or vitamins or supplements within 2 weeks before joining.
- Are pregnant, may be pregnant, are breastfeeding, or want to become pregnant during treatment or within 3 months after the last dose.
- Have certain positive hepatitis B, hepatitis C, or HIV tests. Exceptions apply when follow-up tests show no detectable virus; hepatitis B and HIV exceptions have added requirements.
- Have a condition the study drug could worsen, or the study doctor decides you are not able to take part safely.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (7)
NJ
- Memorial Sloan Kettering at Basking Ridge (All protocol activities) · Basking Ridge, NJ 07920Steven Horwitz, MD · Study contact · 646-608-2680More trials in Basking Ridge
- Memorial Sloan Kettering Monmouth (All protocol activities) · Middletown, NJ 07748Steven Horwitz, MD · Study contact · 646-608-2680More trials in Middletown
- Memorial Sloan Kettering Bergen (All Protocol Activities) · Montvale, NJ 07645Steven Horwitz, MD · Study contact · 646-608-2680More trials in Montvale
NY
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities) · Commack, NY 11725Steven Horwitz, MD · Study contact · 646-608-2680More trials in Commack
- Memorial Sloan Kettering Westchester (All protocol activities) · Harrison, NY 10604Steven Horwitz, MD · Study contact · 646-608-2680More trials in Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) · New York, NY 10065Steven Horwitz, MD · Study contact · 646-608-2680More trials in New York
- Memorial Sloan Kettering Nassau (All protocol activities) · Uniondale, NY 11553Steven Horwitz, MD · Study contact · 646-608-2680More trials in Uniondale