Table 6.

Randomized GVHD Prevention Trials with Calcineurin Inhibitor and Methotrexate

Study	aGVHD Prophylaxis	Intensity	No. of Patients	Graft Type	Graft Source	HLA Match	aGVHD III–IV, %	cGVHD at 2 yr, %	NRM at 2 yr, %
Ratanatharathorn 1998 Ph III	CSA/MTX versus Tac/MTX	Full	329	BM	SD	6/6	17 versus 13	49 versus 55	28 versus 35*
Nash 2000 Ph III	CSA/MTX versus Tac/MTX	Full	180	BM	UD	6/6†	25 versus 17	70 versus 76	33 versus 42
Finke 2009 Ph III	CSA/MTX- −/+ ATGF	Full	202	PBSC	UD	10/10‡	24 versus 11	58 versus 30	28 versus 19
Perkins 2010 Ph II	Tac/MTX versus Tac/MMF	Full	89	PBSC	Mixed	10/10§	4 versus 19‖	56 versus 58*,#	30 versus 32*
Pidala 2012 Ph II	Tac/MTX versus Tac/Siro	Full	97	PBSC	Mixed	8/8	11 versus 14	64 versus 24‖ at 30 m	8 versus 28‖
Cutler 2012 Ph III	Tac/MTX versus Tac/Siro	Full	304	PBSC	SD	6/6	15 versus 8‖	43 versus 54‖,¶	NA

Tac indicates tacrolimus; GVHD, graft-versus-host disease; aGVHD, acute GVHD; BM, bone marrow; PBSC, peripheral blood stem cells; UD, unrelated donor; SD, sibling donor; NA, not available; CSA, cyclosporine A; MTX, methotrexate; MMF, mycophenolate mofetil; Siro, sirolimus; ATGF, ATG fresenius.

^*Estimated from the curve or from the tables.

^†About 18% of the patients had at least 1 antigen mismatch. Also HLA C typing was not done.

^‡HLA C mismatch in 14% to 20% of patients.

^§HLA 9/10 or 10/10 matched donors were included (the author did not specify the percentage of mismatched donors).

^‖Statistically significant.

^¶At unknown duration of follow-up.

^#Moderate or severe cGVHD.