Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Stages IB-IV MF or SS
Stages IB-IV MF or SS
At least 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
Disqualifiers
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 2 weeks prior to 1st day of treatment)
Pregnant or breastfeeding
Active autoimmune disease or history deemed by the investigator to be clinically significant
Trial design
Design model
Single group
Treatments tested in this trial
Mogamulizumab
DrugAdministered 1 mg/kg as an intravenous infusion over at least 60 minutes on Days 1, 8, 15, and 22 of the first 28 day cycle and on Days 1 and 15 of each subsequent cycle.
LD TSEBT
RadiationPatients will receive total skin dose of 12 Gy fractionated at 4 to 6 Gy per week, for 2-3 weeks
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: LD TSEBTExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Overall response rate (ORR)
Response to treatment will be assessed as the number and proportion of participants who achieve either a complete response (CR) or partial response (PR). The outcome is reported as numbers without dispersion. Clinical response will be assessed as follows. * CR: Complete disappearance of all clinical evidence of disease * PR: Decrease in size or amount of measurable disease lesions * Progressive disease (PD): Worsening of lesions; appearance of new lesions; or recurrence of lesions * Stable disease (SD): Disease status that is neither CR, PR, nor PD.
Time frame
12 monthsSecondary outcomes
1
Time-to-Next Significant Treatment (TTNT)
Time-to-next significant treatment (TTNT) will be assessed as the amount of time from starting study treatment through the initiation of any non study systemic therapy. The outcome will be reported as the median TTNT.
Time frame
3 years2
Progression free survival (PFS)
Progression free survival (PFS) will be assessed as the amount of time from starting study treatment to progression of disease (PD) or death due to any cause.
Time frame
3 years3
Duration of response (DOR)
Duration of response (DOR) will be assessed in those participants who achieve either a complete response (CR) or partial response (PR), and with duration as time to progressive disease or the initiation of a non-study systemic therapy. * CR: Complete disappearance of all clinical evidence of disease * PR: Decrease in size or amount of measurable disease lesions * Progressive disease (PD): Worsening of lesions; appearance of new lesions; or recurrence of lesions * Stable disease (SD): Disease status that is neither CR, PR, nor PD.
Time frame
3 years4
Patient reported Quality of Life (QoL)
The Skindex 29 survey was used to evaluate the effect of skin conditions on participant's quality of life (QoL). Surveys were administered at the beginning of every treatment cycle and continuing through up to 3 years of treatment. The survey is a 30 item questionnaire with possible answers scored as 1 to 5, with a score of 1 indicating no negative effect, and a score of 5 indicating a constant ("all the time") negative effect. Response ranges are from 30 to 150. The outcome will be reported as the median QoL score with standard deviation.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov