Reduced Brentuximab Vedotin Doses in Treating Patients with Stage IB-IV Mycosis Fungoides, Sezary Syndrome, and Lymphomatoid Papulosis

Inclusion Criteria

• MYCOSIS FUNGOIDES AND SEZARY SYNDROME: 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.
• MYCOSIS FUNGOIDES AND SEZARY SYNDROME: Eastern Cooperative Oncology Group (ECOG) performance score =< 2.
• MYCOSIS FUNGOIDES AND SEZARY SYNDROME: For Cohort 1, patients who have not received brentuximab vedotin are eligible.
• MYCOSIS FUNGOIDES AND SEZARY SYNDROME: 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.
• MYCOSIS FUNGOIDES AND SEZARY SYNDROME: Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment.
• MYCOSIS FUNGOIDES AND SEZARY SYNDROME: 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 principal investigator (PI).
• MYCOSIS FUNGOIDES AND SEZARY SYNDROME: If human immunodeficiency virus (HIV)+, patient must be on stable anti-retroviral treatment for 12 weeks prior to cycle 1 day 1 (C1D1), with CD4 count > 200 within 7 days prior to C1D1.
• MYCOSIS FUNGOIDES AND SEZARY SYNDROME: Females of childbearing potential must be on acceptable form of birth control per institutional standard.
• LYMPHOMATOID PAPULOSIS: Pathologically confirmed CD30+ lymphomatoid papulosis at the enrolling institution.
• LYMPHOMATOID PAPULOSIS: Requiring systemic treatment per investigator’s discretion.
• LYMPHOMATOID PAPULOSIS: ECOG performance score =< 2.
• LYMPHOMATOID PAPULOSIS: Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment.
• LYMPHOMATOID PAPULOSIS: 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.
• LYMPHOMATOID PAPULOSIS: 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.
• LYMPHOMATOID PAPULOSIS: Females of childbearing potential must be on acceptable form of birth control per institutional standard

Exclusion Criteria

• Concurrent use of other systemic anti-cancer agents or treatments for mycosis fungoides/Sezary syndrome, or lymphomatoid papulosis.
• Grade 2 or greater neuropathy.
• Severe renal impairment (creatinine clearance [CrCL] < 30 mL/min).
• Moderate or severe hepatic impairment (Child-Pugh B or Child-Pugh C).
• Women of reproductive potential must have a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy test within 1 week of C1D1. They should discuss contraception with treating provider. * A female of reproductive potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).
• Previous use of brentuximab vedotin (for Cohort 1 ONLY).
• Receiving systemic therapy for another primary malignancy (other than T-cell lymphoma). * Patients with more than one type of lymphoma may be enrolled after discussion with the Memorial Sloan Kettering (MSK) principal investigator. * Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy (other than T-cell lymphoma) is permissible after discussion with the MSK principal investigator.
• For Cohort 2, patients who previously progressed on the standard 1.8 mg/kg dose and schedule of brentuximab vedotin are ineligible.