Table 2. Active ongoing studies for... | American Society of Hematology

Table 2.

Active ongoing studies for systemic treatment in up-front or steroid-refractory chronic GVHD

Phase	Treatment	Drug mechanism/target	Indication	Enrollment	Primary end point	NCT number
Pilot	Itacitinib	JAK inhibitor	Steroid refractory	40	ORR at 6 months	NCT04200365
Phase 2	Itacitinib and ECP	JAK inhibitor, Treg	Up-front	58	ORR at 24 weeks; dose-limiting toxicity	NCT0446182
Phase 1	SHR0302	JAK inhibitor	Up-front	30	Adverse events	NCT04146207
Phase 1	Abatacept	T-cell costim blockade	Steroid refractory	22	Maximum tolerated dose	NCT01954979
Phase 2/3	Itacitinib	JAK inhibitor	Up-front	431	Dose determination; ORR at 6 months	NCT03584516
Phase 2	Mesenchymal stem cells	Immunomodulatory	Up-front	152	ORR at 12 weeks	NCT04692376
Phase 2	IL-2 and ECP	Treg	Steroid refractory	24	ORR at 4 weeks	NCT03007238
Phase 1/2	Ofatumumab	CD20 B-cell antibody	Up-front	44	ORR at 6 months; maximum tolerated dose	NCT010680965
Phase 2	KD025 (belumosudil)	ROCK inhibitor	Steroid refractory	166	ORR at 6 months	NCT03640481
Phase 2	Acalabrutinib	BTK inhibitor	Recurrent/progressive	50	Best response at 6 months	NCT04198922
Phase 1/2	Glasdegib	Hedgehog signaling inhibitor	Sclerosis/steroid-refractory	21	Maximum tolerated dose	NCT03415867
Phase 2	Ibrutinib/rituximab	BTK inhibitor/CD20 B-cell antibody	Up-front	35	Off immunosuppression at 8 weeks	NCT04235036
Phase 1	Leflunomide	Immunomodulatory	Steroid dependent	24	Dose-limiting toxicity	NCT04212416
Phase 2	Axalitimab	CSF-1 inhibitor	Steroid refractory	210	ORR at 6 months	NCT04710576
Phase 2	Ibrutinib	BTK inhibitor	Up-front	40	ORR at 6 months	NCT04294641
Phase 1/2	Baricitinib	JAK inhibitor	Steroid refractory	31	Safety and efficacy	NCT02759731
Phase 3	Ruxolitinib	JAK inhibitor	Steroid refractory	330	ORR at day 168	NCT03112603

Phase	Treatment	Drug mechanism/target	Indication	Enrollment	Primary end point	NCT number
Pilot	Itacitinib	JAK inhibitor	Steroid refractory	40	ORR at 6 months	NCT04200365
Phase 2	Itacitinib and ECP	JAK inhibitor, Treg	Up-front	58	ORR at 24 weeks; dose-limiting toxicity	NCT0446182
Phase 1	SHR0302	JAK inhibitor	Up-front	30	Adverse events	NCT04146207
Phase 1	Abatacept	T-cell costim blockade	Steroid refractory	22	Maximum tolerated dose	NCT01954979
Phase 2/3	Itacitinib	JAK inhibitor	Up-front	431	Dose determination; ORR at 6 months	NCT03584516
Phase 2	Mesenchymal stem cells	Immunomodulatory	Up-front	152	ORR at 12 weeks	NCT04692376
Phase 2	IL-2 and ECP	Treg	Steroid refractory	24	ORR at 4 weeks	NCT03007238
Phase 1/2	Ofatumumab	CD20 B-cell antibody	Up-front	44	ORR at 6 months; maximum tolerated dose	NCT010680965
Phase 2	KD025 (belumosudil)	ROCK inhibitor	Steroid refractory	166	ORR at 6 months	NCT03640481
Phase 2	Acalabrutinib	BTK inhibitor	Recurrent/progressive	50	Best response at 6 months	NCT04198922
Phase 1/2	Glasdegib	Hedgehog signaling inhibitor	Sclerosis/steroid-refractory	21	Maximum tolerated dose	NCT03415867
Phase 2	Ibrutinib/rituximab	BTK inhibitor/CD20 B-cell antibody	Up-front	35	Off immunosuppression at 8 weeks	NCT04235036
Phase 1	Leflunomide	Immunomodulatory	Steroid dependent	24	Dose-limiting toxicity	NCT04212416
Phase 2	Axalitimab	CSF-1 inhibitor	Steroid refractory	210	ORR at 6 months	NCT04710576
Phase 2	Ibrutinib	BTK inhibitor	Up-front	40	ORR at 6 months	NCT04294641
Phase 1/2	Baricitinib	JAK inhibitor	Steroid refractory	31	Safety and efficacy	NCT02759731
Phase 3	Ruxolitinib	JAK inhibitor	Steroid refractory	330	ORR at day 168	NCT03112603

ECP, extracorporeal photopheresis; ORR, overall response rate; ROCK, rho-associated coiled-coil kinase.