Table 1. Select trials in NHL Trial .... | American Society of Hematology

Table 1.

Select trials in NHL

Trial	clinicaltrials.gov identifier	Disease	InO schedule	No. of patients	ORR, % (CR, %)	VOD	Notes
Phase 1 MTD²²		R/R NHL	0.4-2.4 mg/m² once per cycle	79	39	1/79	Determined MTD of 1.8 mg/m²
Phase 1²³	NCT00717925	R/R Follicular NHL	1.3-1.8 mg/m² once per cycle	13	85 (54 CR)	None	Tested in Japanese population
Phase 1 combining InO and rituximab²⁶	NCT00724971	R/R NHL	1.8 mg/m² once per cycle	10	80	None	Tested in Japanese population
Phase 1/2 combining InO and rituximab²⁵	NCT00299494	Relapsed FL, relapsed DLBCL, refractory aggressive NHL	1.8 mg/m² once per cycle	118	87% Fl, 74% DLBCL, 20% refractory aggressive NHL	None	Tested combination therapy
Phase 2²⁴	NCT00868608	Refractory indolent NHL	1.8 mg/m² once per cycle	81	67 (31)	None
Phase 3 combining InO and rituximab vs R-chemo²⁷	NCT01232556	R/R aggressive NHL	1.8 mg/m² once per cycle	338	41 vs 44 (R-InO vs R-chemo)	3/338	Compared with R-bendamustine or R-gemcitabine; stopped early for futility

Trial	clinicaltrials.gov identifier	Disease	InO schedule	No. of patients	ORR, % (CR, %)	VOD	Notes
Phase 1 MTD²²		R/R NHL	0.4-2.4 mg/m² once per cycle	79	39	1/79	Determined MTD of 1.8 mg/m²
Phase 1²³	NCT00717925	R/R Follicular NHL	1.3-1.8 mg/m² once per cycle	13	85 (54 CR)	None	Tested in Japanese population
Phase 1 combining InO and rituximab²⁶	NCT00724971	R/R NHL	1.8 mg/m² once per cycle	10	80	None	Tested in Japanese population
Phase 1/2 combining InO and rituximab²⁵	NCT00299494	Relapsed FL, relapsed DLBCL, refractory aggressive NHL	1.8 mg/m² once per cycle	118	87% Fl, 74% DLBCL, 20% refractory aggressive NHL	None	Tested combination therapy
Phase 2²⁴	NCT00868608	Refractory indolent NHL	1.8 mg/m² once per cycle	81	67 (31)	None
Phase 3 combining InO and rituximab vs R-chemo²⁷	NCT01232556	R/R aggressive NHL	1.8 mg/m² once per cycle	338	41 vs 44 (R-InO vs R-chemo)	3/338	Compared with R-bendamustine or R-gemcitabine; stopped early for futility

R-, rituximab.