A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1 (NCT06698003) | Clinical Trial Compass
RecruitingPhase 2
A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1
United States134 participantsStarted 2024-11-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Minimum dose and schedule of mogamulizumab to reduce the proviral load by ≥75%