RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2 Single Center, Single Arm, Open Label Mogamulizumab Combined Upfront With Low Dose Total Skin Electron Beam Therapy (LD TSEBT) in Patients With Mycosis Fungoides (MF) and Sézary Syndrome (SS)

Quick Facts

Study Start:2020-03-30

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04256018

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Stages 1B IV MF or SS * 1 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 * ≥ 18 years of age * 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/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 discussion with the Protocol Director. * Adequate hematologic function * 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) * Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3); or if known bone marrow involvement, then platelets ≥ 75,000 cells/μL (≥ 75,000/mm3). * Adequate hepatic function * 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 graft vs host disease (GvHD) and receiving immunosuppressive therapy. * Women of childbearing potential (WOCBP) must have a negative pregnancy test. * 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.	* MF with limited disease (Stage IA) or central nervous system (CNS) disease * Concomitant corticosteroid use. (with the exception that topical steroid and oral prednisone are allowed at ≤ 20 mg/day, if patient has been on a stable dose for at least 4 weeks prior to study treatment) * Pregnant or breastfeeding * 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.

Inclusion Criteria

Exclusion Criteria

* Stages 1B IV MF or SS
* 1 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
* ≥ 18 years of age
* 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/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 discussion with the Protocol Director.
* Adequate hematologic function
* 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)
* Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3); or if known bone marrow involvement, then platelets ≥ 75,000 cells/μL (≥ 75,000/mm3).
* Adequate hepatic function
* 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 graft vs host disease (GvHD) and receiving immunosuppressive therapy.
* Women of childbearing potential (WOCBP) must have a negative pregnancy test.
* 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.

* MF with limited disease (Stage IA) or central nervous system (CNS) disease
* Concomitant corticosteroid use. (with the exception that topical steroid and oral prednisone are allowed at ≤ 20 mg/day, if patient has been on a stable dose for at least 4 weeks prior to study treatment)
* Pregnant or breastfeeding
* 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.

Contacts and Locations

Study Contact

Zainab Ahmed

CONTACT

650-387-4436

zahmed01@stanford.edu

Principal Investigator

Youn H Kim, MD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Stanford Cancer Center

Stanford, California, 94304

United States

Collaborators and Investigators

Sponsor: Stanford University

Youn H Kim, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-30

Study Completion Date2026-12

Study Record Updates

Study Start Date2020-03-30

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

CTCL

Additional Relevant MeSH Terms

Sezary Syndrome
Mycosis Fungoides