Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease

140 mg capsules for a dose of 420 mg daily by mouth for up to 12 months.

At screening.

"Participants should have PFTs if not performed ≤3 months prior to start of study treatment and Cycle 7, Day 1 (6 months).~Optional at Cycle 12, Day 28 (12 months) and Cycle 24, Day 28 (24 months)."

Non-contrast CT at baseline and later during the study if clinically indicated.

0.5-2mg/kg/day allowed for clinical disease stabilization during first 4 weeks after starting Ibrutinib.

At any dose.

"As clinically indicated. At doses less than or equal to suspension 200 mg twice a day (BID) if ibrutinib dose modified to 280 mg once daily.~OR Posaconazole suspension 200 mg three times a day (TID) or 400 mg BID if Ibrutinib dose modified to 140 mg once daily.~OR Posaconazole injection intravenous (IV) injection 300 mg once daily; or delayed-release capsules 300 mg once daily if Ibrutinib dose modified to 140 mg once daily.."

Treat or prevent bronchiolitis obliterans.

Treat or prevent bronchiolitis obliterans.

Treat or prevent gastrointestinal acute graft-versus host disease (GvHD).

Treat or prevent gastrointestinal acute graft-versus host disease (GvHD).

Neutrophil growth factor permitted per institutional policy

Neutrophil growth factor permitted per institutional policy.

Red cell growth factor permitted per institutional policy.

According to institutional policy.

Optional. Baseline, Cycle 7, Day 1 (6 months), Cycle 12, Day 28 (12 months) and Cycle 24, Day 28.