A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Mogamulizumab
DrugCohort 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
Treatment groups
134 Participants
are divided into 2 treatment groupsGroup A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months from baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov