Extracorporeal Photopheresis in Sezary Syndrome
ConditionSezary Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorOleg E. Akilov, MD, PhD
About this trial
The primary endpoint is to determine if ECP induces a decrease in % of tumor cells after treatment. 20 patients with Sezary Syndrome will receive ECP weekly x4, then bi-weekly for 5 months. Each patient will donate 5 samples to determine immune responses in peripheral blood. Additional clinical assessments will be a modified skin weighted assessment and flow cytometry at baseline and months 3 and 6. A CT scan will be obtained at baseline and only repeated if pathology is present at baseline. The tumor microenvironment will be studied by comparing transcriptomics of the blood samples before, 1 day after first ECP treatment, cycle 1, 1, 3 and 6 months after ECP treatment by scRNAseq (5 samples total per patient ).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with an established diagnosis of Sezary syndrome (stage IVA1)
Patients amenable for ECP
The patient must have a minimum wash-out period of 3 weeks between the last dose of prior systemic therapy
Patients should have recovered from all adverse events related to prior therapy to ≤ grade 1
Disqualifiers
Visceral metastasis of lymphoma
Concomitant administration of radiotherapy or systemic anti-cancer therapy including but not restricted to: chemotherapy, biological agents, or immunotherapy
Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection.
Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol.
Trial population
Patients with Sezary syndrome
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Extracorporeal photopheresis (ECP)
DeviceExtracorporeal photopheresis is a process that exposes a collection of white blood cells and plasma to a light sensitizing agent, methoxsalen, and returns that compartment to the body.
Methoxsalen Injection
DrugMethoxsalen is a light-sensitizing sterile compound added to the collected white blood cells and plasma during ECP.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Sezary Syndrome2 interventions
Trial outcomes
Primary outcomes
1
Change from baseline in tumor-specific immunity
Evaluate immune responses post ECP using innovative technology such as single-cell RNA sequencing (scRNAseq) coupled with TCR sequencing to characterize ECP-related change in malignant cells
Time frame
Up to 3 months post baseline2
Change from baseline in tumor-specific immunity
Evaluate immune responses post ECP using innovative technology such as single-cell RNA sequencing (scRNAseq) coupled with TCR sequencing to characterize ECP-related change in malignant cells
Time frame
Up to 6 months post baselineSecondary outcomes
1
Change from baseline in the objective response rate for ECP therapy
.Evaluate response in skin and blood using a modified skin weighted assessment tool that assess the tumor burden in the skin and blood flow cytometry that assesses the tumor burden in the blood. If tumor burden detected internally (visceral) or in the lymph nodes at baseline, follow up CT scans will be used to evaluate lymph nodal and/or visceral response. Response rate is defined as 50% or greater decrease in skin, lymph node/visceral, or blood tumor burden
Time frame
Up to 3 months post baseline2
Change from baseline in the objective response rate for ECP therapy
.Evaluate response in skin and blood using a modified skin weighted assessment tool that assess the tumor burden in the skin and blood flow cytometry that assesses the tumor burden in the blood. If tumor burden detected internally (visceral) or in the lymph nodes at baseline, follow up CT scans will be used to evaluate lymph nodal and/or visceral response. Response rate is defined as 50% or greater decrease in skin, lymph node/visceral, or blood tumor burden
Time frame
Up to 6 months post baselineOther outcomes
1
Change from baseline in the objective response rate by disease compartment
Evaluation of objective responses separated out by each subgroup of potential involvement (blood, skin, lymph nodes,and viscera (if present).
Time frame
Up to 3 months post baseline2
Change from baseline in the objective response rate by disease compartment
Evaluation of objective responses separated out by each subgroup of potential involvement (blood, skin, lymph nodes,and viscera (if present).
Time frame
Up to 6 months post baseline3
Correlation of clinical responses and changes in tumor microenvironment in the blood.
Technology using scRNAseq to analyze the blood microenvironment will be correlated with the clinical responses observed.
Time frame
Up to 6 months post baselineSponsors and contacts
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Source ClinicalTrials.gov