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Recruiting Phase 2 NCT03587844

Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients

Trial Parameters

Condition Mycosis Fungoides
Sponsor Memorial Sloan Kettering Cancer Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 58
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2018-07-03
Completion 2026-07
Interventions
brentuximab vedotinbrentuximab vedotinbrentuximab vedotin

Brief Summary

The purpose of this study is to test any good and bad effects of the study drug called brentuximab vedotin at a lower dose than is FDA-approved.

Eligibility Criteria

Inclusion Criteria: Mycosis fungoides (MF) and Sezary Syndrome (SS) 1. Pathologically confirmed mycosis fungoides/sezary syndrome at the enrolling institution, disease stage IB (defined as patches, plaque, or papules that involve 10% of the skin surface viscera) or higher ° CD30 negative mycosis fungoides patients are eligible. 2. Age ≥ 18 years 3. ECOG Performance Score ≤ 2 4. For Cohort 1, patients who have not received brentuximab vedotin are eligible. 5. For Cohort 2, patients who have previously had brentuximab vedotin for MF/SS are eligible. Patients previously treated on Cohort 1 who were discontinued due to toxicity are not eligible for Cohort 2. 6. Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment. ° See section 6.2 Subject Exclusion Criteria for guidelines regarding adjuvant and maintenance therapy for prior malignancy. 7. Topical or systemic steroids (equivalent to ≤ 10 mg/day of prednisone) may be considered if dose has be

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