RecruitingPhase 2

Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients

United States58 participantsStarted 2018-07-03

Plain-language 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.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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.

✕. 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
✕. 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.

overall response

Timeframe: 1 year

NCT IDNCT03587844

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07

Alison Moskowitz, MD

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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.

✕. 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
✕. 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.