search
Back to results

Photopheresis in Early-stage Mycosis Fungoides

Primary Purpose

Cutaneous T Cell Lymphoma, Mycosis Fungoides

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis
THERAKOS® CELLEX photopheresis system
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous T Cell Lymphoma focused on measuring photopheresis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. 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. Exclusion Criteria: 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.

Sites / Locations

  • Herbert Irving PavilionRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UVA Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis System

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Duration of Response
Duration of response (DOR) will be calculated from time of response to documentation of progression or death.
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.
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.
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.
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.
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.

Full Information

First Posted
November 12, 2022
Last Updated
May 26, 2023
Sponsor
Columbia University
Collaborators
Mallinckrodt, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05680558
Brief Title
Photopheresis in Early-stage Mycosis Fungoides
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2021 (Actual)
Primary Completion Date
December 14, 2025 (Anticipated)
Study Completion Date
July 25, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Mallinckrodt, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous T Cell Lymphoma, Mycosis Fungoides
Keywords
photopheresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UVA Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis
Other Intervention Name(s)
UVADEX® with THERAKOS® CELLEX Photopheresis
Intervention Description
Extracorporeal Photopheresis (ECP)
Intervention Type
Device
Intervention Name(s)
THERAKOS® CELLEX photopheresis system
Intervention Description
THERAKOS® CELLEX is an FDA-approved extra-corporeal photopheresis system
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
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.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Time to Response of Photopheresis Therapy
Description
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).
Time Frame
1 Year
Title
Duration of Response
Description
Duration of response (DOR) will be calculated from time of response to documentation of progression or death.
Time Frame
1 Year
Title
Change in Functional Assessment of Cancer Therapy - General (FACT-G) Score
Description
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.
Time Frame
Baseline and 1 Year
Title
Change in Skindex-29 Score
Description
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.
Time Frame
Baseline and 1 Year
Title
Change in Short Form Survey (SF-36v2) Score
Description
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.
Time Frame
Baseline and 1 Year
Title
Change in Size of Lymph Nodes
Description
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.
Time Frame
Baseline and 1 Year
Title
Change in Sézary Cell Counts at 6 and at 12 months
Description
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.
Time Frame
Baseline, 6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Larisa Geskin, MD
Phone
212-305-5293
Email
ljg2145@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larisa Geskin, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herbert Irving Pavilion
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larisa Geskin, MD
Phone
212-305-5293
Email
ljg2145@cumc.columbia.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Photopheresis in Early-stage Mycosis Fungoides

We'll reach out to this number within 24 hrs