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Can a cancer drug stop leukemia before it starts?

NCT ID NCT06698003

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether the drug mogamulizumab can prevent adult T-cell leukemia/lymphoma (ATL) in people infected with HTLV-1 who are at high risk. About 134 participants will receive low doses of the drug over several weeks. The goal is to see if it can reduce the virus levels in the blood enough to stop cancer from developing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mogamulizumab
What this could lead to
If successful, this could offer a way to prevent a rare but aggressive blood cancer in people carrying the HTLV-1 virus.
What could go wrong
This is a small, early-phase trial (phase 2) with only 134 participants, so results may not apply to everyone. The drug may not reduce viral load enough or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 134 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    RECRUITING

    New York, New York, 10065, United States

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

    RECRUITING

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth (All protocol activities)

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (All protocol activities)

    RECRUITING

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester (All protocol activities)

    RECRUITING

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering at Basking Ridge (All protocol activities)

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

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