A Phase 2 Study for Screening and Prevention of Adult T-cell Leukemia/Lymphoma With Mogamulizumab in High-Risk Carriers of HTLV-1

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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.

Locations
United States
New Jersey
Memorial Sloan Kettering at Basking Ridge (All protocol activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (All protocol activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (All Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (All protocol activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (All protocol activities)
RECRUITING
Uniondale
Contact Information
Primary
Steven Horwitz, MD
horwitzs@MSKCC.ORG
646-608-2680
Backup
Alison Moskowitz, MD
moskowia@mskcc.org
646-608-3726
Time Frame
Start Date: 2024-11-15
Estimated Completion Date: 2029-11-15
Participants
Target number of participants: 134
Treatments
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
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov

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