Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients

Recruiting now · Phase 2

Conditions studied: Mycosis Fungoides, Lymphomatoid Papulosis, Sezary Syndrome

In brief

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.

Key facts

Study ID

NCT03587844

Run by

Memorial Sloan Kettering Cancer Center

People needed

58

Starts

2018-07-03

Expected to finish

2027-07-01

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Mycosis fungoides (MF) and Sezary Syndrome (SS)
• 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.
• Age ≥ 18 years
• ECOG Performance Score ≤ 2
• For Cohort 1, patients who have not received brentuximab vedotin are eligible.
• 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.
• 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.
• 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.
• Lymphomatoid papulosis (LyP)
• Pathologically confirmed lymphomatoid papulosis at the enrolling institution
• Requiring systemic treatment per investigator's discretion
• Age ≥ 18 years
• ECOG Performance Score ≤ 2
• Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment.
• 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.
• 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 institutional standard

You may not qualify if…

• 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 (CrCL <30 mL/min)
• Moderate or severe hepatic impairment (Child-Pugh B or Child-Pugh C)
• ° See Appendix E for Child Pugh Classification chart
• Women of reproductive potential† must have a negative Serum ß human chorionic gonadotropin (ß-HCG) pregnancy test within 1 week of C1D1. They should discuss contraception with treating provider.
• 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 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 1.8mg/kg dose and schedule of brentuximab vedotin are ineligible.
• 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).

Where it is running

• Stanford University Medical Center — Stanford, California, United States (enrolling)
• Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Commack — Commack, New York, United States (enrolling)
• Memorial Sloan Kettering Westchester — East White Plains, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Nassau — Uniondale, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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