A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06698003
Phase
PHASE2
Status
Recruiting
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Conditions

  • Lymphoma
  • T-Cell Leukemia/Lymphoma, Adult
  • T-cell Leukemia
  • T-cell Leukemia/Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mogamulizumab — DRUG
    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 Details

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.

Key Dates

First listed
Nov 20, 2024
Start date
Nov 15, 2024
Status verified
Mar 2026
Primary completion
Nov 15, 2029
Completion
Nov 15, 2029

Study Design

Enrollment
134 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Cohort 1: 0.3 mg/kg of mogamulizumab every 12 weeks, for 2 total doses
  • Experimental: Cohort 2
    Cohort 2: 0.3 mg/kg of mogamulizumab every 6 weeks, for 4 total doses

Primary Outcome Measure

Minimum dose and schedule of mogamulizumab to reduce the proviral load by ≥75% [ Time Frame: 6 months from baseline ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (All protocol activities)Basking RidgeNew Jersey07920
Steven Horwitz, MD
646-608-2680
Memorial Sloan Kettering Monmouth (All protocol activities)MiddletownNew Jersey07748
Steven Horwitz, MD
646-608-2680
Memorial Sloan Kettering Bergen (All Protocol Activities)MontvaleNew Jersey07645
Steven Horwitz, MD
646-608-2680
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities)CommackNew York11725
Steven Horwitz, MD
646-608-2680
Memorial Sloan Kettering Westchester (All protocol activities)HarrisonNew York10604
Steven Horwitz, MD
646-608-2680
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Steven Horwitz, MD
646-608-2680
Memorial Sloan Kettering Nassau (All protocol activities)UniondaleNew York11553
Steven Horwitz, MD
646-608-2680

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering at Basking Ridge (All protocol activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (All protocol activities)· Middletown, NJMemorial Sloan Kettering Bergen (All Protocol Activities)· Montvale, NJMemorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities)· Commack, NYMemorial Sloan Kettering Westchester (All protocol activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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