T-Cell Leukemia/Lymphoma, AdultPhase 2NCT06698003
A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1
A Phase 2 study testing Mogamulizumab in people with T-Cell Leukemia/Lymphoma, Adult and T-cell Leukemia/Lymphoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T-Cell Leukemia/Lymphoma, Adult, T-cell Leukemia/Lymphoma, T-cell Leukemia
- What is being tested?
- Mogamulizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 7 sitesUnited States
- Study dates
- 15 Nov 2024to 15 Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, 07920
Steven Horwitz, MD, 646-608-2680
- Recruiting
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities)
Commack, New York, 11725
Steven Horwitz, MD, 646-608-2680
- Recruiting
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604
Steven Horwitz, MD, 646-608-2680
- Recruiting
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748
Steven Horwitz, MD, 646-608-2680
- Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Steven Horwitz, MD, 646-608-2680
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Steven Horwitz, MD, 646-608-2680
- Recruiting
Memorial Sloan Kettering Nassau (All protocol activities)
Uniondale, New York, 11553
Steven Horwitz, MD, 646-608-2680
About this study
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
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.
- Being tested
- Mogamulizumab
- Keywords
- T-Cell Leukemia/Lymphoma, Adult, T-cell Leukemia/Lymphoma, T-cell leukemia, Lymphoma, Mogamulizumab, HTLV-1, Memorial Sloan Kettering Cancer Center, 21-486
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, T-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MogamulizumabDrug
Cohort 1: 0.3 mg/kg of mogamulizumab every 12 weeks, for 2 total doses Cohort 2: 0.3 mg/kg of mogamulizumab every 6 weeks, for 4 total doses
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Cohort 1: 0.3 mg/kg of mogamulizumab every 12 weeks, for 2 total doses Receives: Drug: Mogamulizumab |
| Cohort 2 | Experimental | Cohort 2: 0.3 mg/kg of mogamulizumab every 6 weeks, for 4 total doses Receives: Drug: Mogamulizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum dose and schedule of mogamulizumab to reduce the proviral load by ≥75%
To define the minimum efficacious dose and schedule of mogamulizumab to reduce the proviral load by ≥75% by pre-emptive treatment of HTLV-1 carriers with a limited course of mogamulizumab. The minimum efficacious dose will maintain ≥75% reduction in PVL from baseline levels for a minimum 6 months post completion of preemptive treatment with a limited course of mogamulizumab.
Measured: 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start15 Nov 2024
- Primary completion15 Nov 2029 (estimated)
- Study completion15 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-Cell Leukemia/Lymphoma, AdultStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Horwitz, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698003
- Sponsor's protocol ID
- 21-486
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06698003
- Acronym / sponsor ID
- 21-486
- Keywords
- T-Cell Leukemia/Lymphoma, Adult, T-cell Leukemia/Lymphoma, T-cell leukemia, Lymphoma, Mogamulizumab, HTLV-1, Memorial Sloan Kettering Cancer Center, 21-486
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Nov 2029 (estimated)
- Study completion
- 15 Nov 2029 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: MogamulizumabCohort 1: 0.3 mg/kg of mogamulizumab every 12 weeks, for 2 total doses |
| Cohort 2 | Experimental | Drug: MogamulizumabCohort 2: 0.3 mg/kg of mogamulizumab every 6 weeks, for 4 total doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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 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
Key exclusion criteria (22 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MogamulizumabCohort 1: 0.3 mg/kg of mogamulizumab every 12 weeks, for 2 total doses Cohort 2: 0.3 mg/kg of mogamulizumab every 6 weeks, for 4 total doses | Drug | Cohort 1, Cohort 2 |
Primary outcome
Minimum dose and schedule of mogamulizumab to reduce the proviral load by ≥75%
Time frame: 6 months from baseline
To define the minimum efficacious dose and schedule of mogamulizumab to reduce the proviral load by ≥75% by pre-emptive treatment of HTLV-1 carriers with a limited course of mogamulizumab. The minimum efficacious dose will maintain ≥75% reduction in PVL from baseline levels for a minimum 6 months post completion of preemptive treatment with a limited course of mogamulizumab.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Horwitz, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mogamulizumab in people with T-Cell Leukemia/Lymphoma, Adult and T-cell Leukemia/Lymphoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven Horwitz, MD (646-608-2680, horwitzs@MSKCC.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum dose and schedule of mogamulizumab to reduce the proviral load by ≥75% (time frame: 6 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.