Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome

STATUS

Recruiting
End date

Aug 25, 2024
participants needed

30
sponsor

Stanford University

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Updated on 25 April 2022

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malignant disease

metastases

antibiotic therapy

antibiotics

cancer

lymphoma

monoclonal antibodies

retinoids

interferon

imiquimod

immunosuppressive therapy

bone marrow procedure

gilbert's syndrome

vorinostat

progressive disease

neutrophil count

immunosuppressants

alemtuzumab

cancer therapy

phototherapy

t-cell lymphoma

sezary syndrome

romidepsin

renal function test

mycosis

electron beam therapy

cutaneous t-cell lymphoma

total skin electron beam therapy

metastatic tumor

mogamulizumab

nitrogen mustard

Summary

The purpose of this study is to determine the efficacy of the combination of LD-TSEBT and mogamulizumab in patients with MF and SS. And to evaluate the secondary measures of clinical benefit of the combination therapy and to evaluate the safety and tolerability of the combination in patients with MF and SS.

Description

Primary Objective:To determine the efficacy of the combination of LD TSEBT and mogamulizumab in patients with MF and SS

Secondary Objective: To evaluate the secondary measures of clinical benefit of the combination therapy and to evaluate the safety and tolerability of the combination in patients with MF and SS

Details

Condition	Sezary Syndrome, Mycosis Fungoides
Treatment	Mogamulizumab, LD TSEBT
Clinical Study Identifier	NCT04256018
Sponsor	Stanford University
Last Modified on	25 April 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Stages 1B IV MF or SS
	prior standard of care therapy
	Prior LD TSEBT (> 3 months prior) and prior mogamulizumab is allowed, as long as progressive disease (PD) did not occur while on therapy, and did not discontinue due to toxicities
	The Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
	All clinically significant toxic effects of prior cancer therapy resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE, v 5.0)
	MF and a known history of non complicated staphylococcus colonization/infection is eligible provided that stable doses of prophylactic antibiotics continue
	The following minimum wash out from previous treatments are required, if applicable
	≥ 4 weeks for retinoids, interferons, Vorinostat, romidepsin, pralatrexate, or other systemic anti cancer/cutaneous T-cell lymphoma (CTCL) therapies
	≥ 2 weeks for phototherapy, local radiation therapy
	≥ 2 weeks for topical therapy (including topical steroid, retinoid, nitrogen mustard, or imiquimod)
	≥ 12 weeks for total skin electron beam therapy
	≥ 4 weeks for monoclonal antibodies; except > 12 weeks for alemtuzumab
	Rapidly progressive malignant disease may be enrolled prior to above periods after
	Adequate hematologic function
	discussion with the Protocol Director
	Absolute neutrophil count (ANC) ≥ 1,500 cells/μL (≥ 1,500/mm3); or if known bone marrow involvement, then ANC ≥ 1,000 cells/μL (≥ 1,000/mm3)
	Adequate hepatic function
	Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3); or if known bone marrow involvement, then platelets ≥ 75,000 cells/μL (≥ 75,000/mm3)
	Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN). Exception: If Gilbert's syndrome; then ≤ 5 times ULN
	Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN; or ≤ 5.0 x ULN in the presence of known hepatic involvement by CTCL
	Adequate renal function
	Serum creatinine ≤ 1.5 x ULN; or
	Calculated creatinine clearance > 50 mL/min using the Cockcroft Gault formula
	If prior allogeneic hematopoietic stem cell transplant (HSCT), then must be free of
	Women of childbearing potential (WOCBP) must have a negative pregnancy test
	graft vs host disease (GvHD) and receiving immunosuppressive therapy
	WOCBP must agree to use effective contraception during the study and for 3 months after the last dose
	Male participants and their female partners of child bearing potential must be willing to use an appropriate method of contraception during the study and for 3 months after the last dose
Exclusion Criteria
	MF with limited disease (Stage IA) or central nervous system (CNS) disease
	Current evidence of large cell transformed disease
	_ Concomitant corticosteroid use. (Topical steroid and oral prednisone are
	weeks prior to study entry)
	Pregnant or breastfeeding
	allowed at ≤ 20 mg/day, if patient has been on a stable dose for at least 4
	Active autoimmune disease or history deemed by the investigator to be clinically significant
	Known human immunodeficiency virus (HIV) positivity; known human T cell lymphotropic virus (HTLV 1) infection; or active hepatitis B or C
	Active herpes simplex or herpes zoster. Those receiving prophylaxis for herpes and who started taking medication at least 30 days prior to the Screening Visit, and have no active signs of active infection, and whose last active infection was more than 6 months ago, may enter the study, and should continue to take the prescribed medication for the duration of the study

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Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome