Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
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 test any good and bad effects of the study drug called brentuximab vedotin at a lower dose than is FDA-approved.
Eligibility criteria
Qualifiers
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
Age ≥ 18 years
ECOG Performance Score ≤ 2
For Cohort 1, patients who have not received brentuximab vedotin are eligible.
Disqualifiers
Topical or systemic steroids (equivalent to ≤ 10 mg/day of prednisone) may be considered if dose has been constant and discontinuation may lead to rebound flare in disease, adrenal insufficiency, and/or unnecessary suffering, after discussion with PI.
If HIV+, patient must be on stable anti-retroviral treatment for 12 weeks prior to C1D1, with CD4 count >200 within 7 days prior to C1D1.
Females of childbearing potential must be on acceptable form of birth control per instutional standard.
Pathologically confirmed lymphomatoid papulosis at the enrolling institution
Trial design
Treatments tested in this trial
- brentuximab vedotin
- brentuximab vedotin
- brentuximab vedotin
Treatment groups
58 Participants
are divided into 3 treatment groupsSponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
Seagen Inc.
Collaborator
Source ClinicalTrials.gov