Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

Hematologic Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Dermatologic Agents

Methoxsalen

Photosensitizing Agents

UVADEX® is supplied in a 10 mL single-use vial. Each mL of solution contains 20 mcg of UVADEX®.

In the ECP process, UVADEX® will be injected directly into the Recirculation Bag of the extracorporal circuit after completion of the buffy coat collection, just prior to pressing the photoactivation button. The dose of UVADEX used to inoculate these cells will be calculated based on the treatment volume collected during the plasma/buffy coat collection process, usinge the following formula :

Treatment Volume in mL x 0.017 = Dose of UVADEX® (in mLs) required for administration into the recirculation bag.

After the cells are inoculated with UVADEX, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then reinfused back into the patient.

methoxsalen

In the ECP process, UVADEX® will be injected directly into the Recirculation Bag of the extracorporeal circuit after completion of the buffy coat collection, just prior to pressing the photoactivation button.

After the cells are inoculated with UVADEX, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then reinfused back into the patient.

Extracoporal Photopheresis (ECP)

Mauricette Michallet, Professor

Aline Praire

Olivier Hequet, MD

ECP will be given to the patients \[UVAR®XTS TM Therakos system, Johnson \& Johnson\] according to the following schedule:

Starting at day 21 after transplant, if hematologic recovery allowed it: 2 ECP per week the first 2 weeks, and 1 ECP per week during 1 month.

Total = 8 ECP after transplantation.

Extracorporal Photopheresis Pilot Study

Allogenic Hematopoietic Stem Cell Transplantation (HSCT) From a Genoidentical Donor After a Reduced Intensity Conditioning Transplantation (RICT) Followed by an Early Preventive Treatment (Day 21) With Extracorporal Photopheresis After Transplantation.

All types of toxicity will be assessed and graded according to NCI/NIH Common Toxicity Criteria

TRM at 3 months for acute GVHD and at 1 year for chronic GVHD

Hospices Civils de Lyon

Nervous System Diseases

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Multiple Sclerosis

Multiple Sclerosis, Chronic Progressive

Sclerosis

Neoplasm Metastasis

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Neoplastic Processes

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Glucocorticoids

Hormones

Hormone Antagonists

Protective Agents

Antineoplastic Agents, Hormonal

Patients will receive 1 gram of IV SoluMedrol over 1 hour, once every month for 12 months.

Patient will receive an Extracorporeal Photopheresis treatment at a set frequency over the course of 1 year. The treatment takes about 2-3 hours per session to complete. The treatment schedule is as follows:

ECP will be administered according to the following schedule:

Study Arm: Weeks 1-8: 3 times per week Weeks 9-16: Twice per week Weeks 17-36: Treatment on two consecutive days every 2 weeks (or optionally, one treatment per week) Weeks 37-43: Once every 2 weeks Weeks 44-52: Once every 4 Weeks

Infusion of drug subcutaneously, once a month.

SoluMedrol

This intervention is the placement of up to two IV's to extract your blood as a set volume, separate out the white cells and return the red cells to your body. Then the white cells are treated with a drug called UVADEX (methoxsalen), excited by a UV light and returned to your body. Once IV is to withdraw your blood and the other is to return your blood to your body.

Extracorporeal Photopheresis

Benjamin Segal, MD

Daniel Couriel, MD

In this research study, the investigators will determine whether a procedure called Extracorporeal Photopheresis (ECP) is helpful in preventing progression of disability in people with SPMS when compared to monthly corticosteroid infusions. This study will determine whether ECP has an effect on inflammatory cells in people with SPMS and whether it has a beneficial therapeutic effect.

This is a Phase II randomized, open-label study to evaluate the efficacy of extracorporeal photopheresis (ECP) versus IVMP on disability progression in subjects with SPMS. At the initial screening visit, an extensive medical history will be obtained and a detailed neurological examination will be performed to determine eligibility. Subjects who meet eligibility criteria will be enrolled in one of two study arms. Subjects will be randomized at a 1:1 ratio to receive ECP (study arm) or active treatment with intravenous methylprednisolone pulses (control arm) administered every 4 Weeks (1 gram per infusion) for 52 weeks.

ECP will be administered according to the following schedule:

Study Arm: Weeks 1-8: 3 times per week Weeks 9-16: Twice per week Weeks 17-36: Treatment on two consecutive days every 2 weeks (or optionally, one treatment per week) Weeks 37-43: Once every 2 weeks Weeks 44-52: Once every 4 Weeks

All subjects, including patients who receive corticosteroids, will be evaluated using the MSFC tool at baseline and every 3 months through 2 years. They will also be scored using the EDSS at baseline and every 3 months through 2 years. Subjects in the control arm will be evaluated by MSFC and EDSS during the week prior to their next intravenous methylprednisolone infusion and every three months from baseline through two year mark. Blood will be collected for immune function (cytokines) testing at baseline, and months 3, 6, 9 and 12. MRI will be done at baseline as well as months 6 and 12 following initiation of treatment; if the disability measurements are stable or improved at any point in time, then ECP will be continued per protocol..

Patients in the ECP arm should have all of their treatments with the CELLEX ® System. Patients randomized to the ECP arm must receive their treatment within 5 days of baseline visit.

In the ECP process, UVADEX ® (methoxsalen) Sterile Solution will be injected directly the recirculation bag of the extracorporeal circuit after completion of the buffy coat collection. The dose of UVADEX® (methoxsalen) Sterile Solution will be calculated based on the standard treatment volume formula.

Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple Sclerosis

A Randomized, Controlled, Open-Label Study to Evaluate the Efficacy of Extracorporeal Photopheresis (ECP) Versus Corticosteroids in the Treatment of Patients With Secondary Progressive Multiple Sclerosis (SPMS)

MSFC score is a composite score calculated from 3 tests: 1) Timed 25-Foot walk (leg function); 2) 9-Hole Peg Test (arm function); and 3) Paced Auditory Serial Addition Test (cognitive function). The results are combined to create a single score (the MSFC Z-Score) to measure performance and change over time in subjects with MS. MSFC Z-score = {Z arm + Z leg + Z cognitive} / 3.0. A positive score indicates that, on average, an individual performed better than the reference population and a negative score indicates that, on average, an individual performed worse than the reference population.

The Expanded Disability Status Scale (EDSS) is used to quantify disability due to symptoms of MS and to track changes in disability status over time. Scores range from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Scores are determined by performing a neurological exam and given in increments of 0.5.

Changes in immunological parameters that occur following initiation of ECP or corticosteroids and any relevant correlation with clinical outcomes

Mallinckrodt

University of Utah

M.D.

Patients will receive 1 gram of IV SoluMedrol over 1 hour, once every month for 12 months.

SoluMedrol: Infusion of drug subcutaneously, once a month.

Corticosteriod Arm

Patient will receive an Extracorporeal Photopheresis treatment at a set frequency over the course of 1 year. The treatment takes about 2-3 hours per session to complete. The treatment schedule is as follows:

ECP will be administered according to the following schedule:

Study Arm: Weeks 1-8: 3 times per week Weeks 9-16: Twice per week Weeks 17-36: Treatment on two consecutive days every 2 weeks (or optionally, one treatment per week) Weeks 37-43: Once every 2 weeks Weeks 44-52: Once every 4 Weeks

Extracorporeal Photopheresis: This intervention is the placement of up to two IV's to extract your blood as a set volume, separate out the white cells and return the red cells to your body. Then the white cells are treated with a drug called UVADEX (methoxsalen), excited by a UV light and returned to your body. Once IV is to withdraw your blood and the other is to return your blood to your body.

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

MSFC score is a composite score calculated from 3 tests: 1) Timed 25-Foot walk (leg function); 2) 9-Hole Peg Test (arm function); and 3) Paced Auditory Serial Addition Test (cognitive function). The results are combined to create a single score (the MSFC Z-Score) to measure performance and change over time in subjects with MS. MSFC Z-score = {Z arm + Z leg + Z cognitive} / 3.0. A positive score indicates that, on average, an individual performed better than the reference population and a negative score indicates that, on average, an individual performed worse than the reference population.

Multiple Sclerosis Functional Composite (MSFC)

The Expanded Disability Status Scale (EDSS) is used to quantify disability due to symptoms of MS and to track changes in disability status over time. Scores range from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Scores are determined by performing a neurological exam and given in increments of 0.5.

Expanded Disability Status Scale (EDSS)

Analysis of the data in this study was severely limited by the high dropout rate and low enrollment numbers. Given that only 2/13 participants completed the study, we do not have enough outcome data to complete a meaningful analysis.

Dr. Daniel Couriel

EDSS Score

MSFC Z-Score

Study participants assigned to ECP treatment

ECP Arm

Study participants assigned to corticosteroid treatment

Corticosteroid Arm

Baseline MSFC and EDSS scores were captured for all 13 subjects, however some subjects withdrew immediately after baseline. Withdrawal of additional subjects continued from that point. Only 1 patient from the ECP arm made it to the 12 month visit. Four patients from the CS arm made it to 12 mos, however 1 of the 4 declined the MSFC tests.

Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)

Due to low enrollment numbers and a high dropout rate, there was insufficient data to analyze and correlate treatment with clinical outcomes. Only 2 subjects continued to the 24 month completion, both were corticosteroid patients. No ECP subjects made it to 24 mos. Therefore, there was no analysis performed on the 2 year data.

Immunological Parameters in Relation to SPMS

Overall Study

Syndrome

Lymphoma

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Leukemia, Myeloid

Graft vs Host Disease

Hodgkin Disease

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Myeloid Leukemia

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Homologous Wasting Disease

Hodgkin Lymphoma

Patients will receive 2 ECP treatments on day -10 and day -8 and then for two consecutive days every two weeks starting from post engraftment (ANC \> 500) up to day 90 (total of 10 treatments). This may be given as an outpatient procedure.

Patients will receive 2 ECP treatments prior to the commencement of the high dose chemotherapy and then for two consecutive days every two weeks starting from post engraftment (ANC \> 500) up to day 90 (total of 10 treatments). This may be given as an outpatient procedure.

The dose of UVADEX® used to inoculate these cells will be calculated based on the treatment volume collected during the plasma/buffy coat collection process, using the following formula:

Treatment Volume in mL X 0.017 of UVADEX® (20 mcg/ml) required for administration into the recirculation bag = Amount of UVADEX® (in mLs) required for administration into the recirculation bag.

After the cells are inoculated with UVADEX®, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then re-infused back into the patient.

extracorporeal photopheresis

Sunil Abhyankar, MD

To study the effect of ECP with Uvadex® in conjunction with a standard myeloablative conditioning regimen on the incidence of acute and chronic GvHD in patients undergoing an allogeneic related or unrelated BMT or PBSC transplant, for treatment of hematologic or lymphoproliferative malignancies.

This study is to test the concept that using ECP treatment prior to and after an allogeneic bone marrow transplant (BMT) or peripheral blood stem cell (PBSC) transplant will prevent the development of GvHD. This study is not designed to detect a specific treatment effect. However, some statements about the outcome of the study are possible. A sample size of n = 21 patients could detect a statistically significant difference between the expected rate of GvHD in an untreated population, 60%, and our hypothesized rate, 30%, for the matched-unrelated recipients. This calculation is based on a one-sample, two-sided chi-square test at the 5% level of significance with 80% power.

Patients will receive ECP from day -10 and day -8 before transplant and then from day of engraftment absolute neutrophil count (ANC\>500) until day 90 after transplant. Patients who enter the study will receive a BMT or PBSC transplant from a donor who is matched unrelated (8/10 to 10/10 match). Rates of acute GvHD and chronic GvHD that occur in patients are 50-70% for the matched-unrelated donor transplant.

The choice of sample size is 21 patients. The analysis will determine if there are favorable trends for a treatment effect. Comparison on survival, and rates of acute and chronic GvHD will be made with historical controls who have undergone similar myeloablative transplant from an unrelated donor.

Test Extracorporeal Photopheresis (ECP) Treatment Before/After Allogeneic Bone Marrow Transplant (BMT) or Peripheral Blood Stem Cell (PBSC) Transplant to Prevent Graft Versus Host Disease

A Study of Extracorporeal Photopheresis With UVADEX® in the Setting of a Standard Myeloablative Conditioning Regimen in Related or Unrelated Donor Hematopoietic Stem Cell Transplantation for the Prevention of Graft Versus Host Disease

The primary efficacy variable is the presence/absence of grade II-IV acute GvHD within the first 100 days after transplantation

These secondary efficacy variables for a patient are dichotomous:

* the development of cGvHD during 365 days after transplantation (and which body sites are involved)
* the relapse of primary disease (hematologic or lymphoproliferative malignancy)
* the grade of aGvHD
* the involved sites of cGvHD

University of Kansas Medical Center

Infections

Mycoses

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Mycosis Fungoides

Lymphoma, T-Cell, Cutaneous

Sezary Syndrome

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Bacterial Infections

Communicable Diseases

Bacterial Infections and Mycoses

Peripheral T-cell Lymphoma

Cutaneous T-cell Lymphoma

Antibodies

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Mogamulizumab

Immunologic Factors

Patients receive mogamulizumab IV over 60 minutes on days 1, 8, 15, 22, of cycle 1 and days 1 and 15 of subsequent cycles. Beginning in cycle 2, patients also undergo ECP over 3 hours on days 8, 9, 22,and 23. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving CR)/PR after 6 cycles receive up to 6 additional cycles of treatment in the absence of disease progression or unacceptable toxicity.

Quality-of-Life Assessment

Questionnaire Administration

Christiane R. Querfeld

Christiane R Querfeld

This phase II trial studies the effect of extracorporeal photopheresis (ECP) and mogamulizumab in treating patients with erythrodermic cutaneous T cell lymphoma (CTCL), a type of skin lymphoma. CTCL is a rare type of cancer that begins in the white blood cells called T cells. Erythrodermic is a widespread red rash that may cover most of the body. ECP is a medical treatment that removes blood with a machine, isolates white blood cells and exposes them to ultra violet light, then returns the cells to the body. Mogamulizumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving mogamulizumab with ECP may work together to kill the tumor cells directly (with mogamulizumab) and boost immune response to cancer (with ECP).

PRIMARY OBJECTIVE:

I. To assess tolerability and overall response rate (ORR) of the (ECP)/mogamulizumab regimen in CTCL patients previously untreated with mogamulizumab.

SECONDARY OBJECTIVES:

I. To estimate complete response (CR) rate, time to response, duration of response, progression free survival, and overall survival in CTCL patients treated with the ECP/mogamulizumab combination.

II. To summarize the toxicities in CTCL patients treated with the ECP/mogamulizumab combination.

EXPLORATORY OBJECTIVES:

I. To assess quality of life (QoL) parameters before, during, and after the regimen.

II. To evaluate the anti-tumor and immunomodulatory effects of mogamulizumab in the CTCL microenvironment in skin and blood samples of erythrodermic CTCL patients.

III. To evaluate the immunomodulatory effects of ECP.

OUTLINE:

Patients receive mogamulizumab intravenously (IV) over 60 minutes on days 1, 8, 15, 22, of cycle 1 and days 1 and 15 of subsequent cycles. Beginning in cycle 2, patients also undergo ECP over 3 hours on days 8, 9, 22,and 23. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR)/partial response (PR) after 6 cycles receive up to 6 additional cycles of treatment in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, then for up to 12 months.

Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma

A Phase II Study of Combination Extracorporeal Photopheresis (ECP) and Mogamulizumab in Erythrodermic CTCL

ORR will be calculated as the proportion of evaluable patients that have confirmed complete response (CR) or partial response (PR), as defined according to global response assessment. Exact 95% confidence intervals will be calculated for these estimates.

Toxicity and adverse events will be recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events 5.0 scale. Observed toxicities will be summarized by type, severity, date of onset, and attribution.

Defined as the proportion of response-evaluable patients that have a documented CR.

Will be estimated using the product-limit method of Kaplan and Meier.

National Cancer Institute (NCI)

City of Hope Medical Center

INDUCTION (WEEKS 1-7): Patients receive mogamulizumab IV over 60 minutes on days 1, 8, 15, 22, and 36 in the absence of disease progression progression and unacceptable toxicity. Patients also undergo extracorporeal photopheresis on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression and unacceptable toxicity.

TREATMENT (CYCLES 1-12): Patients receive mogamulizumab IV over 60 minutes on days 1 and 15, and undergo extracorporeal photopheresis on days 1 and 15 of cycles 1-6, then day 1 of subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression and unacceptable toxicity.

MAINTENANCE (CYCLES 13+): Patients with clinical benefit may continue extracorporeal photopheresis on day 1. Cycles repeat every 28 days in the absence of disease progression and unacceptable toxicity.

Pamela B. Allen, MD

Pamela B Allen, MD

David Reagan

Pamela B Allen

This phase Ib/II trial investigates the side effects of mogamulizumab and extracorporeal photopheresis and to see how well they work in treating patients with Sezary syndrome or mycosis fungoides. Mogamulizumab (a humanized antibody) binds to CCR4, a protein often found in high amounts on T-cell lymphoma cells. Binding to these cells may slow their growth, as well as mark them for attack by the immune system. Extracorporeal photopheresis (ECP) is a standard treatment for cancers that affects the skin, and may work by killing some lymphoma cells directly and by boosting the body's immune response against other lymphoma cells. Giving mogamulizumab together with ECP may work better in treating patients with Sezary syndrome or mycosis fungoides compared to either therapy alone.

PRIMARY OBJECTIVES:

I. To evaluate the safety and tolerability of the combination of mogamulizumab and ECP in Sezary syndrome (SS) and erythrodermic mycosis fungoides (MF).

II. To determine the efficacy of the combination of mogamulizumab and extra-corporeal photopheresis in SS and erythrodermic MF.

SECONDARY OBJECTIVE:

I. To assess response by disease compartment, time to response, duration of response, progression free survival (PFS), and change in quality of life in patients with Sezary syndrome and erythrodermic MF treated with mogamulizumab and ECP.

TERTIARY/EXPLORATORY OBJECTIVE:

I. To assess biomarkers of response and changes in immunologic response on serial blood samples and peripheral blood flow cytometry.

OUTLINE:

INDUCTION (WEEKS 1-7): Patients receive mogamulizumab intravenously (IV) over 60 minutes on days 1, 8, 15, 22, and 36 in the absence of disease progression progression and unacceptable toxicity. Patients also undergo extracorporeal photopheresis on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression and unacceptable toxicity.

TREATMENT (CYCLES 1-12): Patients receive mogamulizumab IV over 60 minutes on days 1 and 15, and undergo extracorporeal photopheresis on days 1 and 15 of cycles 1-6, then day 1 of subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression and unacceptable toxicity.

MAINTENANCE (CYCLES 13+): Patients with clinical benefit may continue extracorporeal photopheresis on day 1. Cycles repeat every 28 days in the absence of disease progression and unacceptable toxicity.

After completion of study treatment, patients are followed up for 90 days, then every 3 months for 3 years.

Mogamulizumab and Extracorporeal Photopheresis for the Treatment of Sezary Syndrome or Mycosis Fungoides

Mogamulizumab and Extracorporeal Photopheresis (ECP) for the Treatment of Sézary Syndrome and Erythrodermic Mycosis Fungoides, a Phase 1b/2 Study

Correlation of baseline genomic and immunologic profiles with response. Will analyze baseline samples using hierarchical clustering to identify patterns associated with different response patterns and kinetics. Will describe baseline immunologic profiles descriptively.

Cytokines will be assessed via the Luminex panel.

Measuring genomic profiles of the tumor and immune cells from peripheral blood and biopsy samples at specific time points.

Descriptive statistics (n, frequency and percentage) of toxicities and number of DLT's during the DLT window per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be reported. Corresponding listings of data will be generated. DLT rate will be calculated as proportion (Patients with DLT/Total patients) along with 95% confidence intervals using the Clopper-Pearson method.

Assessed using the Global Response Score (GRS). ORR6 rate will be determined by dividing the number of ORR6's by the total number of evaluable patients. Will be calculated as proportion (Responders/Total patients) along with 95% confidence intervals using the Clopper-Pearson method. Chi-square test or Fisher's exact test will be used to compare the efficacy in term of response rate between the different groups stratified by baseline factors, respectively. Logistic regression model will be further employed to test the adjusted effect of dosage on the response rate after adjusting for other clinical factors and demographic factors.

Assessed using the Global Response Score (GRS), which consists of skin evaluation (modified severity weighted assessment tool \[mSWAT\]), radiographic assessment, and detection of circulating Sezary cells on flow cytometry in patients that have received at least 1 month of combined therapy. Overall response, complete response, and partial response will be calculated as proportions along with 95% confidence intervals using the Clopper-Pearson method.

Based on GRS. Defined as time from the date when criteria for response (complete response \[CR\] or partial response \[PR\]) based on GRS was first met until the date when the response was first lost (date of loss is date when first meets criteria for progressive disease \[PD\] or death). Will be estimated using the Kaplan-Meier method.

Based on GRS. Defined as time from the date of first dosing to the date when criteria for response (CR or PR) based on GRS are first met. Will be estimated using the Kaplan-Meier method.

Estimated by Kaplan-Meier method. Cox proportional hazards models will be further used in the multivariable analyses to assess the patients' OS after adjusting for other factors. Interaction terms between these factors will also be tested for statistical significance. The proportional hazards assumption will be evaluated graphically and analytically with regression diagnostics. Violations of the proportional hazards assumptions will be addressed by use of time-dependent covariates or extended Cox regression models.

Estimated by Kaplan-Meier method. Cox proportional hazards models will be further used in the multivariable analyses to assess the patients' PFS after adjusting for other factors. Interaction terms between these factors will also be tested for statistical significance. The proportional hazards assumption will be evaluated graphically and analytically with regression diagnostics. Violations of the proportional hazards assumptions will be addressed by use of time-dependent covariates or extended Cox regression models.

Adverse events (AEs) will be listed and summarized. Adverse events will also be listed by severity, seriousness, and by system organ class. Will also evaluate toxicities which will be presented in tabular form as appropriate based on grade and attribution. The number and percentage of subjects who experience AEs will be presented in tabular and/or graphical format and summarized descriptively, where appropriate AEs will be presented with and without regard to causality based on the investigator's judgment. The frequency of overall toxicity, categorized by toxicity grades 1 through 5, will be described. Additional summaries will be provided for AEs that are observed with higher frequency.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Extracorporal Photopheresis Pilot Study	NCT00930566	Hematological M...	methoxsalen Extracoporal Ph...	18 Years - 65 Years	Hospices Civils de Lyon
Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple Sclerosis	NCT02296346	Secondary Progr...	SoluMedrol Extracorporeal ...	18 Years - 75 Years	University of Utah
Test Extracorporeal Photopheresis (ECP) Treatment Before/After Allogeneic Bone Marrow Transplant (BMT) or Peripheral Blood Stem Cell (PBSC) Transplant to Prevent Graft Versus Host Disease	NCT01174940	Stem Cell Leuke... Graft Versus Ho...	extracorporeal ...	18 Years -	University of Kansas Medical Center
Test Extracorporeal Photopheresis (ECP) Treatment Before/After Allogeneic Bone Marrow Transplant (BMT) or Peripheral Blood Stem Cell (PBSC) Transplant to Prevent Graft Versus Host Disease	NCT01174940	Stem Cell Leuke... Graft Versus Ho...	extracorporeal ...	18 Years -	University of Kansas Medical Center
Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma	NCT04930653	Folliculotropic... Primary Cutaneo... Sezary Syndrome Stage IB Mycosi... Stage II Mycosi... Stage IIA Mycos... Stage IIB Mycos... Transformed Myc...	Extracorporeal ... Mogamulizumab Quality-of-Life... Questionnaire A...	18 Years -	City of Hope Medical Center
Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple Sclerosis	NCT02296346	Secondary Progr...	SoluMedrol Extracorporeal ...	18 Years - 75 Years	University of Utah
Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple Sclerosis	NCT02296346	Secondary Progr...	SoluMedrol Extracorporeal ...	18 Years - 75 Years	University of Utah
Test Extracorporeal Photopheresis (ECP) Treatment Before/After Allogeneic Bone Marrow Transplant (BMT) or Peripheral Blood Stem Cell (PBSC) Transplant to Prevent Graft Versus Host Disease	NCT01174940	Stem Cell Leuke... Graft Versus Ho...	extracorporeal ...	18 Years -	University of Kansas Medical Center
Mogamulizumab and Extracorporeal Photopheresis for the Treatment of Sezary Syndrome or Mycosis Fungoides	NCT04676087	Mycosis Fungoid... Primary Cutaneo... Sezary Syndrome	Extracorporeal ... Mogamulizumab Quality-of-Life...	18 Years -	Emory University

Spots Global Cancer Trial Database for extracorporeal photopheresis