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NCT03007238 · ClinicalTrials.gov registry record · Phase 2

Extracorporeal Photopheresis and Low Dose Aldesleukin in Treating Patients With Steroid Refractory Chronic Graft-Versus-Host Disease

A Phase 2 study, sponsored by City of Hope Medical Center.

Completed
Registry status
Phase 2
Development phase
10
Enrollment target

NCT03007238: Completed Phase 2 study, sponsored by City of Hope Medical Center.

NCT03007238 is a Phase 2 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03007238, a Phase 2 study, has completed, sponsored by City of Hope Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
10 participants
Enrollment target

Study Summary

This phase II trial studies efficacy of extracorporeal photopheresis and low dose aldesleukin (interleukin-2) in treating patients with chronic graft-versus-host disease (cGVHD) that does not respond to upfront treatment with steroids. In graft-vs-host disease, patients have a small quantity of a white blood cell called T regulatory cells or T-reg cells that helps to control the immune system. Extracorporeal photopheresis is a procedure where patient's blood is removed and treated with ultraviolet light and drugs that become active when exposed to light. The treated blood is then returned to the patient and may be effective in increasing T-reg cells in patients with cGVHD. Aldesleukin increases the activity and growth of white blood cells, and it has shown to enhance T-reg cells in patients with cGVHD and may be effective improving GVHD symptoms.

Primary Outcome

Defined as the proportion of response-evaluable participates that achieve a CR/PR or SD at Week 16 (4 weeks after the end of treatment).

Interventions

  • OTHER Quality-of-Life Assessment
  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Aldesleukin
  • PROCEDURE Extracorporeal Photopheresis

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2017-01-18
Est. Completion 2019-06-26
Phase Phase 2
City of Hope Medical Center

582 total trials

What the finished NCT03007238 record still lists

NCT03007238 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.

NCT03007238 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03007238 about?

NCT03007238 is a clinical study titled "Extracorporeal Photopheresis and Low Dose Aldesleukin in Treating Patients With Steroid Refractory Chronic Graft-Versus-Host Disease". This phase II trial studies efficacy of extracorporeal photopheresis and low dose aldesleukin (interleukin-2) in treating patients with chronic graft-versus-host disease (cGVHD) that does not respond to upfront treatment with steroids. In graft-vs-host disease, patients have a small quantity of a wh...

What is the current status of trial NCT03007238?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2017-01-18. Estimated completion is 2019-06-26.

What interventions are being tested in trial NCT03007238?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Aldesleukin (BIOLOGICAL), Extracorporeal Photopheresis (PROCEDURE).

Who is sponsoring clinical trial NCT03007238?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03007238's enrollment target sits among peer trials

10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03007238, the US trial registry maintained by the National Library of Medicine. NCT03007238 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.