Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients

STATUS

Recruiting
End date

Jul 12, 2023
participants needed

58
sponsor

Memorial Sloan Kettering Cancer Center

Send

Updated on 5 March 2022

See if I qualify

cancer

prednisone

cancer therapy

sezary syndrome

immunomodulator

systemic steroids

brentuximab

adrenal insufficiency

mycosis

mycosis fungoides and sezary syndrome

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.

Details

Condition	Mycosis Fungoides, Lymphomatoid Papulosis, Sezary Syndrome
Treatment	brentuximab vedotin
Clinical Study Identifier	NCT03587844
Sponsor	Memorial Sloan Kettering Cancer Center
Last Modified on	5 March 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
	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
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 (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 human chorionic
	gonadotropin (-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. 8. 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)

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Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients