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New treatment option for T-Cell Leukemia/Lymphoma, Adult
Official title A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1
ClinicalTrials.gov ID: NCT06698003
What this study is testing
What is Mogamulizumab?
Mogamulizumab is an investigational medicine, being studied as a potential treatment for t-cell leukemia/lymphoma, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- High-risk phenotype (PVL≥8% of PBMC)
You likely can't join if
- In order to protect people and avoid any problems in evaluating the study drug, patients who meet any of the following criteria should be excluded...
- 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
See the full eligibility 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...
- 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...
- In order to protect people 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.