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NCT00609609 · ClinicalTrials.gov registry record · Phase 2

Photopheresis for the Treatment of Acute Graft Versus Host Disease

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
81
Enrollment target

NCT00609609: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT00609609 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 81 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00609609, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
81 participants
Enrollment target

Study Summary

The goal of this clinical research study is to find out whether adding extracorporeal photopheresis (ECP) to standard therapy for acute GVHD with corticosteroids improves response to treatment, length of treatment, and survival.

Primary Outcome

Definition of Treatment Failure: No Response according to the following: A) Skin: 1) No change in GVHD stage by day 14; 2) Gut: No change in GVHD stage by Day 7; 3) Liver: No change in GVHD stage by Day 21. B) Progressive Disease (PD): 1) Skin/Gut: Increase in Stage by 72 hours from the start of therapy; 2) Liver: Increase in Stage by Day 14; 3) Initiation of 2nd line treatment at any time for acute GVHD: 4) Any new organ involvement by acute GVHD. C) Inability to Taper: 1) Patient still on \>1

Interventions

  • DRUG Methylprednisolone
  • PROCEDURE Photopheresis

Trial Details

FieldValue
Enrollment Target 81 participants
Start Date 2008-01
Est. Completion 2016-01
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00609609 record still lists

NCT00609609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower).

The record links to 0 conditions, and to 2 interventions - of which Methylprednisolone is the first listed.

NCT00609609 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00609609 about?

NCT00609609 is a clinical study titled "Photopheresis for the Treatment of Acute Graft Versus Host Disease". The goal of this clinical research study is to find out whether adding extracorporeal photopheresis (ECP) to standard therapy for acute GVHD with corticosteroids improves response to treatment, length of treatment, and survival.

What is the current status of trial NCT00609609?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2008-01. Estimated completion is 2016-01.

What interventions are being tested in trial NCT00609609?

The interventions under investigation include: Methylprednisolone (DRUG), Photopheresis (PROCEDURE).

Who is sponsoring clinical trial NCT00609609?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00609609's enrollment target sits among peer trials

81 834th of 2000 higher than 1,159 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 NCT00609609, the US trial registry maintained by the National Library of Medicine. NCT00609609 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.