Trial · NCT05680558
Photopheresis in Early-stage Mycosis Fungoides
NCT05680558, Phase 2, Recruiting, Columbia University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Photopheresis in Early-stage Mycosis Fungoides. Trials, record NCT05680558. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05680558
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Photopheresis in Early-stage Mycosis Fungoides
- NCT number
- NCT05680558
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 74 participants, estimated
- Lead sponsor
- Columbia University
- Conditions
- Cutaneous T Cell Lymphoma, Mycosis Fungoides
- Interventions
- UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis, THERAKOS® CELLEX photopheresis system
- First posted
- 2023-01-11
- Last updated
- 2026-04-27
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate | 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. |
| Secondary | Time to Response of Photopheresis Therapy | 1 Year | 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). |
| Secondary | Duration of Response | 1 Year | Duration of response (DOR) will be calculated from time of response to documentation of progression or death. |
| Secondary | Change in Functional Assessment of Cancer Therapy - General (FACT-G) Score | Baseline and 1 Year | 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. |
| Secondary | Change in Skindex-29 Score | Baseline and 1 Year | 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. |
| Secondary | Change in Short Form Survey (SF-36v2) Score | Baseline and 1 Year | 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. |
| Secondary | Change in Size of Lymph Nodes | Baseline and 1 Year | 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. |
| Secondary | Change in Sézary Cell Counts at 6 and at 12 months | Baseline, 6 months and 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05680558
GET https://conductscience.org/api/trials/v1/NCT05680558/registered