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

Launched by MALLINCKRODT · Jun 23, 2011

Keywords

ClinConnect Summary

The investigation of extracorporeal photopheresis (ECP) plus standard of care (SoC) (SoC+ECP) in chronic graft-versus-host disease (cGVHD) within prospective, randomized clinical studies is limited, despite its frequent clinical use.

This phase 1/pilot study was the first randomized, prospective study to investigate ECP use as first-line therapy in cGVHD, based on the 2015 National Institutes of Health (NIH) consensus criteria for diagnosis and response assessment.

Adult patients with new-onset (≤3 years of hematopoietic stem cell transplantation) moderate or severe cGVHD were randomized ...

Gender

ALL

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:
• • 1. safety and well-being of participant or offspring
• • 2. safety of study staff
• • 3. analysis of results