Cutaneous T Cell LymphomaPhase 2NCT05680558
Photopheresis in Early-stage Mycosis Fungoides
A Phase 2 study testing UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis and THERAKOS® CELLEX photopheresis system in people with Cutaneous T Cell Lymphoma and Mycosis Fungoides, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether photopheresis therapy can be used to improve the clinical course of early stage cutaneous T-cell lymphoma (CTCL). Currently, photopheresis is performed as a palliative treatment for late stage CTCL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T Cell Lymphoma, Mycosis Fungoides
- What is being tested?
- UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis and THERAKOS® CELLEX photopheresis system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2021to Jul 2028
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Who are male or female, over the age of 18 and <40 kg body weight with adequate veins to provide intravenous access.
- Who are willing to adhere to the protocol and sign an Informed Patient Consent Document
- Must not be on any other investigational device/drug treatment.
- Who have the diagnosis of Mycosis Fungoides (MF) including a skin biopsy consistent with MF (atypical epidermotropic or folliculocentric T-cells) with appropriate staging as IA, IB or IIA: T1 or T2 (patches or plaques) with measurable lesions.
- With IA stage must demonstrate a minor blood abnormality by morphology/laboratory assessment.
- With IIA stage - clinically significant nodes (1.5 cm) must have lymph node biopsy showing dermatopathic nodes or no involvement.
Show all 9Show fewer
- Must be willing and able to discontinue concomitant medications for MF. Subjects currently taking the following drugs must discontinue medication with the following wash out periods prior to enrollment in the trial: PUVA or UVB Therapy - 4 weeks, topical nitrogen mustard or other topical chemotherapy - 4 weeks, bexarotene capsules or other systemic biologic agent - 3 weeks washout, high dose topical steroids, topical retinoids or immunotherapy - 2 week washout with 1% topical hydrocortisone , oral steroids above 10 mg - 30 day washout, unless subject has Addison's Disease or adrenal insufficiency
- Who are refractory to at least one of the standard therapies used to treat Stage IA, IB or IIA CTCL such as oral steroids, high-dose topical steroids, topical nitrogen mustard, Bexarotene, PUVA therapy, electron beam radiation, biological response modifiers or oral methotrexate.
- Must be willing to abstain from therapeutic sunbathing, phototherapy, tanning beds, etc. for the duration of the study.
Who cannot join
- Who have MF (T3 cutaneous tumors or T4 exfoliative erythroderma) Stage IIB - IVB
- Who are unable to tolerate extracorporeal volume loss i.e., severe cardiac disease/anemia
- With deterioration of renal function who have a serum creatinine level greater than 3.0 mg/dL.
- With lipemic plasma >500 ng/dL, uncontrolled diabetes, history of liver damage (2.5 x normal alanine transaminase (ALT), aspartate aminotransferase (AST), porphyria, lupus, positive tests for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody or Hepatitis B Surface Antigen, severe emotional, behavioral or psychiatric problems that, in the opinion of the investigator, would result in poor compliance with the treatment regimen, and idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen compounds, heparin, or citrate.
- On oral prednisone therapy or high potency topical steroids.
- Who are pregnant or nursing a child.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Larisa Geskin, MD, 212-305-5293, ljg2145@cumc.columbia.edu
About this study
Official title: THERAKOS® CELLEX Photopheresis System as an Interventional Therapy for the Treatment of Early Stage CTCL (Mycosis Fungoides), an Open-label, Single-arm, Multi-center, Phase II Study
The purpose of this study is to determine whether photopheresis therapy can be used to improve the clinical course of early stage cutaneous T-cell lymphoma (CTCL). Currently, photopheresis is performed as a palliative treatment for late stage CTCL. However, recent studies have demonstrated that patients with early stage CTCL may have markers in their blood which were previously observed primarily in late stage disease, such as clonal T cell populations. Considering these findings, the study aims to investigate whether photopheresis therapy may be used earlier in the disease course to produce a clinical response.
Read the detailed description
The THERAKOS® CELLEX Photopheresis System is currently FDA approved and indicated for the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) in patients not responsive to other forms of treatment. The original studies in CTCL were performed in patients having extensive patch/plaque or erythrodermic stage disease. Therefore, photopheresis is used primarily to treat stage III or IV CTCL. However, studies have shown that 50% of patients with early disease may have clonal T-cells in their peripheral blood if polymerase chain reaction is used to amplify the T-cell receptor gamma gene fragments. Thus, patients who are staged as T1 or T2 who also have slight abnormalities in blood involvement, such as atypical cells seen on blood smear or abnormal flow cytometry may benefit from photopheresis therapy. This study aims to investigate the efficacy of photopheresis therapy in patients with Stage !A, 1B, or IIA CTCL.
- Conditions
- Cutaneous T Cell Lymphoma, Mycosis Fungoides
- Being tested
- UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis, THERAKOS® CELLEX photopheresis system
- Keywords
- photopheresis
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX PhotopheresisDrug
Also called UVADEX® with THERAKOS® CELLEX Photopheresis
Extracorporeal Photopheresis (ECP)
THERAKOS® CELLEX photopheresis systemDevice
THERAKOS® CELLEX is an FDA-approved extra-corporeal photopheresis system
| Study group | Role | What they receive |
|---|---|---|
| UVA Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis System | Experimental | TREATMENT with THERAKOS® CELLEX Photopheresis System on two consecutive days every 2 weeks for the first 3 months; then once per month for following 9 months. Receives: Drug: UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis; Device: THERAKOS® CELLEX photopheresis system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Overall response rate at 1 year measured by the modified skin-weighted assessment tool (mSWAT) in accordance with Olsen et al criteria for response in clinical trial. Measurable lesions are defined as those that can be accurately measured in at least one dimension.
Measured: 1 Year
Secondary outcomes (7)
Time to Response of Photopheresis Therapy
The time to response calculated from time of photopheresis treatment initiation to the first objective response (clearance of skin disease from baseline ≥50%) observed for participants who achieved a complete response (CR) (clearing of all disease manifestations confirmed by biopsy) or partial response (PR) (partial response defined as > 50% improvement in the extent of skin involvement).
Measured: 1 Year
Duration of Response
Duration of response (DOR) will be calculated from time of response to documentation of progression or death.
Measured: 1 Year
Change in Functional Assessment of Cancer Therapy - General (FACT-G) Score
The FACT-G is a 27-item questionnaire designed to measure four health related quality of life in cancer patients. Scores range from 0-108 with a higher score indicating better quality of life.
Measured: Baseline and 1 Year
Change in Skindex-29 Score
The Skindex-29 is a questionnaire with 29 questions that assess the health-related quality of life of patients with skin diseases. Scores range from 0-100 with a higher scoring indicating a worse health status.
Measured: Baseline and 1 Year
Change in Short Form Survey (SF-36v2) Score
The SF-36v2 is a health survey measuring quality of life. Scores range from 0-100 with a higher scoring indicating a better quality of life.
Measured: Baseline and 1 Year
Change in Size of Lymph Nodes
The change in size (single maximum dimension in centimeters) of lymph nodes will be noted as applicable. By definition, the patients should not have pathologically involved lymph nodes.
Measured: Baseline and 1 Year
Change in Sézary Cell Counts at 6 and at 12 months
Change in Sézary cell counts (malignant cells) in blood samples as assessed by flow cytometry. By definition, the enrolled patients will have only minor blood involvement and not leukemia.
Measured: Baseline, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start8 May 2021
- Primary completionMar 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Principal investigator, Larisa Geskin, MD, Columbia University
- Investigators
- Larisa Geskin, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680558
- Sponsor's protocol ID
- AAAS9960
- Status last verified
- Apr 2026
- First submitted
- 12 Nov 2022
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THERAKOS® CELLEX Photopheresis System as an Interventional Therapy for the Treatment of Early Stage CTCL (Mycosis Fungoides), an Open-label, Single-arm, Multi-center, Phase II Study
- ClinicalTrials.gov ID
- NCT05680558
- Acronym / sponsor ID
- AAAS9960
- Conditions
- Cutaneous T Cell Lymphoma, Mycosis Fungoides
- Keywords
- photopheresis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- 8 May 2021 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 11 Jan 2023 (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 purpose of this study is to determine whether photopheresis therapy can be used to improve the clinical course of early stage cutaneous T-cell lymphoma (CTCL). Currently, photopheresis is performed as a palliative treatment for late stage CTCL. However, recent studies have demonstrated that patients with early stage CTCL may have markers in their blood which were previously observed primarily in late stage disease, such as clonal T cell populations. Considering these findings, the study aims to investigate whether photopheresis therapy may be used earlier in the disease course to produce a clinical response.
Detailed description
The THERAKOS® CELLEX Photopheresis System is currently FDA approved and indicated for the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) in patients not responsive to other forms of treatment. The original studies in CTCL were performed in patients having extensive patch/plaque or erythrodermic stage disease. Therefore, photopheresis is used primarily to treat stage III or IV CTCL. However, studies have shown that 50% of patients with early disease may have clonal T-cells in their peripheral blood if polymerase chain reaction is used to amplify the T-cell receptor gamma gene fragments. Thus, patients who are staged as T1 or T2 who also have slight abnormalities in blood involvement, such as atypical cells seen on blood smear or abnormal flow cytometry may benefit from photopheresis therapy. This study aims to investigate the efficacy of photopheresis therapy in patients with Stage !A, 1B, or IIA CTCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UVA Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis System | Experimental | Drug: UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis, Device: THERAKOS® CELLEX photopheresis systemTREATMENT with THERAKOS® CELLEX Photopheresis System on two consecutive days every 2 weeks for the first 3 months; then once per month for following 9 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Who are male or female, over the age of 18 and <40 kg body weight with adequate veins to provide intravenous access.
- Who are willing to adhere to the protocol and sign an Informed Patient Consent Document
- Must not be on any other investigational device/drug treatment.
- Who have the diagnosis of Mycosis Fungoides (MF) including a skin biopsy consistent with MF (atypical epidermotropic or folliculocentric T-cells) with appropriate staging as IA, IB or IIA: T1 or T2 (patches or plaques) with measurable lesions.
- With IA stage must demonstrate a minor blood abnormality by morphology/laboratory assessment.
Key exclusion criteria (6 listed)
- Who have MF (T3 cutaneous tumors or T4 exfoliative erythroderma) Stage IIB - IVB
- Who are unable to tolerate extracorporeal volume loss i.e., severe cardiac disease/anemia
- With deterioration of renal function who have a serum creatinine level greater than 3.0 mg/dL.
- With lipemic plasma >500 ng/dL, uncontrolled diabetes, history of liver damage (2.5 x normal alanine transaminase (ALT), aspartate aminotransferase (AST), porphyria, lupus, positive tests for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody or Hepatitis B Surface Antigen, severe emotional, behavioral or psychiatric problems that, in the opinion of the investigator, would result in poor compliance with the treatment regimen, and idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen compounds, heparin, or citrate.
- On oral prednisone therapy or high potency topical steroids.
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 |
|---|---|---|
| UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX PhotopheresisAlso: UVADEX® with THERAKOS® CELLEX PhotopheresisExtracorporeal Photopheresis (ECP) | Drug | UVA Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis System |
| THERAKOS® CELLEX photopheresis systemTHERAKOS® CELLEX is an FDA-approved extra-corporeal photopheresis system | Device | UVA Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis System |
Primary outcome
Overall Response Rate
Time frame: 1 Year
Overall response rate at 1 year measured by the modified skin-weighted assessment tool (mSWAT) in accordance with Olsen et al criteria for response in clinical trial. Measurable lesions are defined as those that can be accurately measured in at least one dimension.
7 secondary outcomes
Time to Response of Photopheresis Therapy
Time frame: 1 Year
Duration of Response
Time frame: 1 Year
Change in Functional Assessment of Cancer Therapy - General (FACT-G) Score
Time frame: Baseline and 1 Year
Change in Skindex-29 Score
Time frame: Baseline and 1 Year
Change in Short Form Survey (SF-36v2) Score
Time frame: Baseline and 1 Year
Change in Size of Lymph Nodes
Time frame: Baseline and 1 Year
Change in Sézary Cell Counts at 6 and at 12 months
Time frame: Baseline, 6 months and 12 months
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 27 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Larisa Geskin, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis and THERAKOS® CELLEX photopheresis system in people with Cutaneous T Cell Lymphoma and Mycosis Fungoides, run by Columbia University at 1 site 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 9 inclusion and 6 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 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Larisa Geskin, MD (212-305-5293, ljg2145@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2026.