Sezary SyndromeECPNCT05157581
Extracorporeal Photopheresis in Sezary Syndrome
An observational study of Sezary Syndrome, run by Oleg E. Akilov, MD, PhD at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sezary Syndrome
- What is being tested?
- Extracorporeal photopheresis (ECP) and Methoxsalen Injection
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Apr 2023to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Sezary syndrome
Who may be able to join
- 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
- Signed informed consent form prior to any protocol-specific procedures.
Who cannot join
- 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.
- Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.
- Patients with known allergy to Methoxsalen or heparin (as part of SOC ECP procedure).
- Patients who are pregnant. -
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Emory University School of Medicine
Atlanta, Georgia, 30322
Pamela B Allen, MD, MSc, 404-778-6195, pamela.b.allen@emory.edu
Pamela B Allen, MD, MSc
- Recruiting
Cutaneous Translational Research Program - Johns Hopkins Medicine
Baltimore, Maryland, 21287
Toan Bui, BS, 443-856-7329, toanbui9@jhmi.edu
Sima Rozati, MD, PhD
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Charity Ruhl, LPN, 4126472013, ruhlcl@upmc.edu
Nicolena Verardi, PA-C, 412-864-3682, verardin3@upmc.edu
About this study
Official title: Open Label, Single-cohort, and Multi-center Phase II Study Evaluating Tumor-specific Immunity After Extracorporeal Photopheresis in Patients With Sézary Syndrome at Single-cell Resolution
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 ).
Read the detailed description
Cutaneous T-cell lymphoma (CTCL) is a group of skin lymphomas in which malignant lymphocytes infiltrate the skin and, in the later stages, spread to the lymph nodes and blood (leukemia). In the early stages, CTCL generally has a slow course, but in advanced diseases, such as Sezary syndrome (the leukemic form of the disease), there is rapid deterioration. Sezary syndrome is an end-stage variant of CTCL with a mean survival of 1.5 years despite aggressive therapies. Treatment options for the advanced disease are severely limited.
In this study, informed consent will be offered to patients who are candidates for standard of care ECP and have a diagnosis of Sezary Syndrome. Participating patients will undergo ECP twice weekly for 4 weeks then twice monthly for 5 more months (month 6 of therapy). Research blood samples to assess immune responses will be obtained from a blood draw at baseline (before starting ECP), one day after first ECP, and at months 1, 3, and 6. Standard of care assessments to determine the objective response will include measurement of skin tumor burden (mSWAT), blood tumor burden (flow cytometry) and CT scan at baseline and only repeated at month 3 and 6 if lymph node or visceral (organ) involvement identified at baseline.
The investigators propose to establish changes in the tumor microenvironment after ECP, compare transcriptomic differences in malignant lymphocytes, monocytes, DC, and CD8 effectors before and after ECP to test the hypothesis that anti-tumor immune responses can be induced by ECP. We will employ a highly innovative technology such as single-cell RNA sequencing (scRNAseq) coupled with TCR sequencing to characterize ECP-related change in malignant cells utilizing a custom gene set and validate the single-cell protein data by antibody-oligo conjugates. To better understand the relevance of biomarker changes to disease progression, the observed ECP-related changes in tumor microenvironment will be correlated with clinical outcomes.
- Conditions
- Sezary Syndrome
- Being tested
- Extracorporeal photopheresis (ECP), Methoxsalen Injection
- Keywords
- extracorporeal photopheresis
- Medical subject headings
- Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal photopheresis (ECP)Device
Also called ECP, photopheresis
Extracorporeal 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 InjectionDrug
Also called Uvadex
Methoxsalen is a light-sensitizing sterile compound added to the collected white blood cells and plasma during ECP.
| Study group | Role | What they receive |
|---|---|---|
| Sezary Syndrome | 20 subjects with Sezary Syndrome will comprise the single arm of this study Receives: Device: Extracorporeal photopheresis (ECP); Drug: Methoxsalen Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 3 months post baseline
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
Measured: Up to 6 months post baseline
Secondary outcomes (2)
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
Measured: Up to 3 months post baseline
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
Measured: Up to 6 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start4 Apr 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sezary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oleg E. Akilov, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Therakos
- Responsible party
- Sponsor-investigator, Oleg E. Akilov, MD, PhD, University of Pittsburgh
- Investigators
- Oleg E Akilov, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157581
- Sponsor's protocol ID
- STUDY21100115
- Acronym
- ECP
- Status last verified
- Nov 2026
- First submitted
- 16 Nov 2021
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ying Z, Shiue L, Park K, Kollet J, Bijani P, Goswami M, Duvic M, Ni X. Blood transcriptional profiling reveals IL-1 and integrin signaling pathways associated with clinical response to extracorporeal photopheresis in patients with leukemic cutaneous T-cell lymphoma. Oncotarget. 2019 May 7;10(34):3183-3197. doi: 10.18632/oncotarget.26900. eCollection 2019 May 7.
PubMed 31139332Zic JA. Extracorporeal Photopheresis in the Treatment of Mycosis Fungoides and Sezary Syndrome. Dermatol Clin. 2015 Oct;33(4):765-76. doi: 10.1016/j.det.2015.05.011. Epub 2015 Jul 29.
PubMed 26433848Spary LK, Al-Taei S, Salimu J, Cook AD, Ager A, Watson HA, Clayton A, Staffurth J, Mason MD, Tabi Z. Enhancement of T cell responses as a result of synergy between lower doses of radiation and T cell stimulation. J Immunol. 2014 Apr 1;192(7):3101-10. doi: 10.4049/jimmunol.1302736. Epub 2014 Mar 5.
PubMed 24600032Curion F, Handel AE, Attar M, Gallone G, Bowden R, Cader MZ, Clark MB. Targeted RNA sequencing enhances gene expression profiling of ultra-low input samples. RNA Biol. 2020 Dec;17(12):1741-1753. doi: 10.1080/15476286.2020.1777768. Epub 2020 Jun 28.
PubMed 32597303
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Single-cohort, and Multi-center Phase II Study Evaluating Tumor-specific Immunity After Extracorporeal Photopheresis in Patients With Sézary Syndrome at Single-cell Resolution
- ClinicalTrials.gov ID
- NCT05157581
- Acronym / sponsor ID
- ECP / STUDY21100115
- Conditions
- Sezary Syndrome
- Keywords
- extracorporeal photopheresis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oleg E. Akilov, MD, PhDUniversity, hospital or other
- Collaborators
- Therakos
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ).
Detailed description
Cutaneous T-cell lymphoma (CTCL) is a group of skin lymphomas in which malignant lymphocytes infiltrate the skin and, in the later stages, spread to the lymph nodes and blood (leukemia). In the early stages, CTCL generally has a slow course, but in advanced diseases, such as Sezary syndrome (the leukemic form of the disease), there is rapid deterioration. Sezary syndrome is an end-stage variant of CTCL with a mean survival of 1.5 years despite aggressive therapies. Treatment options for the advanced disease are severely limited.
In this study, informed consent will be offered to patients who are candidates for standard of care ECP and have a diagnosis of Sezary Syndrome. Participating patients will undergo ECP twice weekly for 4 weeks then twice monthly for 5 more months (month 6 of therapy). Research blood samples to assess immune responses will be obtained from a blood draw at baseline (before starting ECP), one day after first ECP, and at months 1, 3, and 6. Standard of care assessments to determine the objective response will include measurement of skin tumor burden (mSWAT), blood tumor burden (flow cytometry) and CT scan at baseline and only repeated at month 3 and 6 if lymph node or visceral (organ) involvement identified at baseline.
The investigators propose to establish changes in the tumor microenvironment after ECP, compare transcriptomic differences in malignant lymphocytes, monocytes, DC, and CD8 effectors before and after ECP to test the hypothesis that anti-tumor immune responses can be induced by ECP. We will employ a highly innovative technology such as single-cell RNA sequencing (scRNAseq) coupled with TCR sequencing to characterize ECP-related change in malignant cells utilizing a custom gene set and validate the single-cell protein data by antibody-oligo conjugates. To better understand the relevance of biomarker changes to disease progression, the observed ECP-related changes in tumor microenvironment will be correlated with clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sezary Syndrome | – | Device: Extracorporeal photopheresis (ECP), Drug: Methoxsalen Injection20 subjects with Sezary Syndrome will comprise the single arm of this study |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Sezary syndrome
Key inclusion criteria (5 listed)
- 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
- Signed informed consent form prior to any protocol-specific procedures.
Key exclusion criteria (7 listed)
- 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.
- Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal photopheresis (ECP)Also: ECP, photopheresisExtracorporeal 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. | Device | Sezary Syndrome |
| Methoxsalen InjectionAlso: UvadexMethoxsalen is a light-sensitizing sterile compound added to the collected white blood cells and plasma during ECP. | Drug | Sezary Syndrome |
Primary outcome
Change from baseline in tumor-specific immunity
Time frame: Up to 3 months post baseline
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
Change from baseline in tumor-specific immunity
Time frame: Up to 6 months post baseline
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
2 secondary outcomes
Change from baseline in the objective response rate for ECP therapy
Time frame: Up to 3 months post baseline
Change from baseline in the objective response rate for ECP therapy
Time frame: Up to 6 months post baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 31139332Ying Z, Shiue L, Park K, Kollet J, Bijani P, Goswami M, Duvic M, Ni X. Blood transcriptional profiling reveals IL-1 and integrin signaling pathways associated with clinical response to extracorporeal photopheresis in patients with leukemic cutaneous T-cell lymphoma. Oncotarget. 2019 May 7;10(34):3183-3197. doi: 10.18632/oncotarget.26900. eCollection 2019 May 7.
- Background: PubMed 26433848Zic JA. Extracorporeal Photopheresis in the Treatment of Mycosis Fungoides and Sezary Syndrome. Dermatol Clin. 2015 Oct;33(4):765-76. doi: 10.1016/j.det.2015.05.011. Epub 2015 Jul 29.
- Background: PubMed 24600032Spary LK, Al-Taei S, Salimu J, Cook AD, Ager A, Watson HA, Clayton A, Staffurth J, Mason MD, Tabi Z. Enhancement of T cell responses as a result of synergy between lower doses of radiation and T cell stimulation. J Immunol. 2014 Apr 1;192(7):3101-10. doi: 10.4049/jimmunol.1302736. Epub 2014 Mar 5.
- Background: PubMed 32597303Curion F, Handel AE, Attar M, Gallone G, Bowden R, Cader MZ, Clark MB. Targeted RNA sequencing enhances gene expression profiling of ultra-low input samples. RNA Biol. 2020 Dec;17(12):1741-1753. doi: 10.1080/15476286.2020.1777768. Epub 2020 Jun 28.
- Individual participant dataSharing planned: No
Related trials for Sezary Syndrome
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Mycosis Fungoides, Lymphomatoid Papulosis
Not yet recruitingPhase 2
Golidocitinib in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia
Mycosis Fungoides/Sezary Syndrome, T-cell Large Granular Lymphocytic Leukemia
RecruitingObservational study
A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab
Recurrent Mycosis Fungoides, Recurrent Sezary Syndrome
Active, not recruitingPhase 1
Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome
Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oleg E Akilov, MD, PhD principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sezary Syndrome, run by Oleg E. Akilov, MD, PhD at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charity Ruhl, LPN (4126472013, ruhlcl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in tumor-specific immunity (time frame: Up to 3 months post baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05157581, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.