Early Phase 1 N=60 Randomized Single-blind Treatment

Extracorporeal Photopheresis (ECP) With Methoxsalen for Chronic Graft Versus Host Disease (cGVHD)

Chronic Graft Versus Host Disease

Bottom Line

View on ClinicalTrials.gov: NCT01380535 ↗

Enrolled (actual)

Serious AEs

30.4%

Results posted

Oct 2019

Primary outcome: Primary: Number of Participants With an Overall Response at Week 28 — 20; 14 Participants — p=0.373

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: ECP Methoxsalen (Drug); Standard of Care (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mallinckrodt
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With an Overall Response at Week 28	20; 14	0.373

Summary

Chronic graft-versus-host disease (cGVHD) is a long-lasting complication that can occur after transplants. The transplanted cells seem to fight with the patient's own cells. Extracorporeal photopheresis (ECP) is a fairly new procedure for cGVHD. The participant gets a port to hook up to a machine. The machine removes the white blood cells, mixes them with a light-sensitive drug, shines light on it, and puts all the blood back in. This study will find out if patients respond better if they get ECP with methoxsalen, in addition to the pills normally used to treat cGVHD.

Eligibility Criteria

Inclusion Criteria

To be eligible for inclusion in this trial, the patient must have moderate to severe chronic graft-versus-host disease [defined by the National Institutes of Health (NIH) 2015 Consensus Criteria] that started within 3 years after hematopoietic stem cell transplantation (HSCT).

Exclusion Criteria

Is intolerant to corticosteroids or hypersensitive to methoxsalen
Received certain treatments during time periods disallowed by protocol
Has infections and/or requires treatment that (per protocol or in the opinion of the investigator) might compromise:
safety and well-being of participant or offspring
safety of study staff
analysis of results

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01380535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.