Methoxsalen and Extracorporeal Photopheresis (ECP) for the Treatment of Pediatric Participants With Steroid Refractory Acute Graft Versus Host Disease

Inclusion criteria

• ✓. Male or female 1 to 21 years of age at the time of consent
• ✓. Steroid-refractory grade B-D aGvHD.
• ✓. A Lansky scale Performance Status score ≥ 30
• ✓. Laboratory values are within the following limits, assessed within 3 days of the first study treatment:
• ✓. For participants with isolated upper GI symptoms, pre-Screening biopsy results to confirm diagnosis of aGvHD
• ✓. Female participants of childbearing potential and nonsterilized males who are sexually active with a female partner must be practicing highly effective, reliable, and medically approved contraceptive regimen throughout their participation in the study and for 3 months following the last ECP treatment. Or, for the US only, abstinence may be used in place of an approved contraceptive regimen. Females of childbearing potential are those who have reached the onset of menarche, or 8 years of age, whichever comes first. Approved contraceptive methods for female participants of childbearing potential or nonsterilized males who are sexually active with a female partner are as follows:
• ✓. Signed informed consent/assent is obtained before conducting any study procedures; the parent, legal guardian, or legally authorized representative of a minor must also provide written informed consent

Exclusion criteria