Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients

Last updated: April 8, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Mycosis Fungoides

Sezary Syndrome

Lymphoproliferative Disorders

Treatment

brentuximab vedotin

Clinical Study ID

NCT03587844
18-147
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

Mycosis fungoides (MF) and Sezary Syndrome (SS)

  1. Pathologically confirmed mycosis fungoides/sezary syndrome at the enrollinginstitution, 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.

  1. Age ≥ 18 years

  2. ECOG Performance Score ≤ 2

  3. For Cohort 1, patients who have not received brentuximab vedotin are eligible.

  4. For Cohort 2, patients who have previously had brentuximab vedotin for MF/SS areeligible. Patients previously treated on Cohort 1 who were discontinued due totoxicity are not eligible for Cohort 2.

  5. Previous systemic anti-cancer therapy must have been discontinued at least 2 weeksprior to treatment.

° See section 6.2 Subject Exclusion Criteria for guidelines regarding adjuvant andmaintenance therapy for prior malignancy.

  1. Topical or systemic steroids (equivalent to ≤ 10 mg/day of prednisone) may beconsidered if dose has been constant and discontinuation may lead to rebound flarein disease, adrenal insufficiency, and/or unnecessary suffering, after discussionwith PI.

  2. If HIV+, patient must be on stable anti-retroviral treatment for 12 weeks prior toC1D1, with CD4 count >200 within 7 days prior to C1D1.

  3. Females of childbearing potential must be on acceptable form of birth control perinstutional standard.

Lymphomatoid papulosis (LyP)

  1. Pathologically confirmed lymphomatoid papulosis at the enrolling institution

  2. Requiring systemic treatment per investigator's discretion

  3. Age ≥ 18 years

  4. ECOG Performance Score ≤ 2

  5. Previous systemic anti-cancer therapy must have been discontinued at least 2 weeksprior to treatment.

  6. Topical or systemic steroids (equivalent to ≤ 10 mg/day of prednisone) may beconsidered if dose has been constant and discontinuation may lead to rebound flarein disease, adrenal insufficiency, and/or unnecessary suffering.

  7. If HIV+, patient must be on stable anti-retroviral treatment for 12 weeks prior toC1D1, with CD4 count >200 within 7 days prior to C1D1.

  8. Females of childbearing potential must be on acceptable form of birth control perinstitutional standard

Exclusion

Exclusion Criteria:

  1. Concurrent use of other systemic anti-cancer agents or treatments for mycosisfungoides/sezary syndrome, or lymphomatoid papulosis.

  2. Grade 2 or greater neuropathy

  3. Severe renal impairment (CrCL <30 mL/min)

  4. Moderate or severe hepatic impairment (Child-Pugh B or Child-Pugh C)

° See Appendix E for Child Pugh Classification chart

  1. Women of reproductive potential† must have a negative Serum ß human chorionicgonadotropin (ß-HCG) pregnancy test within 1 week of C1D1. They should discusscontraception with treating provider.

  2. Previous use of brentuximab vedotin (for Cohort 1 ONLY)

  3. Receiving systemic therapy for another primary malignancy (other than T-celllymphoma).

  • Patients with more than one type of lymphoma may be enrolled after discussionwith the MSK Principal Investigator.

  • Adjuvant or maintenance therapy to reduce the risk of recurrence of othermalignancy (other than T-cell lymphoma) is permissible after discussion withthe MSK Principal Investigator.

  1. For Cohort 2, patients who previously progressed on the standard 1.8mg/kg dose andschedule of brentuximab vedotin are ineligible.
  • A female of reproductive potential is a sexually mature female who: has notundergone a hysterectomy or bilateral oophorectomy; or has not been naturallypostmenopausal for at least 24 consecutive months (i.e. has had menses at anytime in the preceding 24 consecutive months).

Study Design

Total Participants: 58
Treatment Group(s): 1
Primary Treatment: brentuximab vedotin
Phase: 2
Study Start date:
July 03, 2018
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Stanford University Medical Center

    Stanford, California 94305-5408
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Commack

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Rockville Centre

    Rockville Centre, New York 11570
    United States

    Site Not Available

  • Memorial Sloan Kettering Nassau

    Uniondale, New York 11553
    United States

    Active - Recruiting

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