Phase
Condition
Mycosis Fungoides
Sezary Syndrome
Lymphoproliferative Disorders
Treatment
brentuximab vedotin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Mycosis fungoides (MF) and Sezary Syndrome (SS)
- 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.
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 areeligible. Patients previously treated on Cohort 1 who were discontinued due totoxicity are not eligible for Cohort 2.
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.
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.
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.
Females of childbearing potential must be on acceptable form of birth control perinstutional 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 weeksprior to treatment.
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.
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.
Females of childbearing potential must be on acceptable form of birth control perinstitutional standard
Exclusion
Exclusion Criteria:
Concurrent use of other systemic anti-cancer agents or treatments for mycosisfungoides/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 chorionicgonadotropin (ß-HCG) pregnancy test within 1 week of C1D1. They should discusscontraception with treating provider.
Previous use of brentuximab vedotin (for Cohort 1 ONLY)
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.
- 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
Connect with a study center
Stanford University Medical Center
Stanford, California 94305-5408
United StatesActive - Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
United StatesActive - Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
United StatesActive - Recruiting
Memorial Sloan Kettering Commack
Commack, New York 11725
United StatesActive - Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York 10604
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York 11570
United StatesSite Not Available
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
United StatesActive - Recruiting
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