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NCT04930653 · ClinicalTrials.gov registry record · Phase 2
Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma
A Phase 2 study of Sezary Syndrome and Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 3
- Study locations
NCT04930653: Recruiting Phase 2 study of Sezary Syndrome and Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, sponsored by City of Hope Medical Center.
NCT04930653 is a Phase 2 study of Sezary Syndrome and Primary Cutaneous T-Cell Non-Hodgkin Lymphoma that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 34 participants, below the 80-participant average among 13 other Sezary Syndrome trials with a reported enrollment target (57% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04930653, a Phase 2 study of Sezary Syndrome and Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 3
- Study locations
Study Summary
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 Outcome
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.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- BIOLOGICAL Mogamulizumab
- PROCEDURE Extracorporeal Photopheresis
Study Locations (3)
Arizona
- Mayo Clinic - Scottsdale
California
- City of Hope Medical Center - Duarte
Georgia
- Winship Cancer Institute of Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2022-10-19 |
| Est. Completion | 2028-06-15 |
| Phase | Phase 2 |
What NCT04930653 shows while recruiting
NCT04930653 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 80-participant average among 13 other Sezary Syndrome trials with a reported enrollment target (57% lower).
The record links to 8 conditions, with Sezary Syndrome appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04930653 reports a single indexed study location in Arizona, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT04930653 about?
NCT04930653 is a clinical study titled "Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma". 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 wide...
What is the current status of trial NCT04930653?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2022-10-19. Estimated completion is 2028-06-15.
What conditions does trial NCT04930653 study?
This clinical trial studies the following conditions: Sezary Syndrome, Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8, Folliculotropic Mycosis Fungoides, Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8.
What interventions are being tested in trial NCT04930653?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Mogamulizumab (BIOLOGICAL), Extracorporeal Photopheresis (PROCEDURE).
Who is sponsoring clinical trial NCT04930653?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04930653 being conducted?
This trial has 3 study locations across Arizona, California, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04930653's enrollment target sits among peer trials
34 7th of 13 higher than 7 of 13 other Sezary Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sezary Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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