Table 3 Trials with salvage regimens in... | American Society of Hematology

Table 3

Trials with salvage regimens in refractory/relapsed AML

Reference	Study design	Regimens	Number of patients	Refractory/ relapsed	Median age (y)	% CR
51	Phase 2	HiDAC vs HiDAC + DXR or DNR	78	42/36	37	63 vs 65 (REF: 20 vs 56)
52	Phase 2	MTZ, etoposide	61	21/20	47	43
53	Phase 2	MTZ, etoposide, IDAC (MEC)	32	18/14	24	66
54	Phase 2	MTZ, etoposide, IDAC (MEC)	74	0/30	37	55
55	Phase 2	IDAC + IDA + etoposide	97	36/61	37	43 (REF: 29)
56	Phase 3, randomized	MTZ, etoposide, AraC + G-CSF vs MTZ, etoposide, AraC	50	6/44	43 vs 47	54 vs 42
57	Phase 3, randomized	HiDAC vs HiDAC + etoposide	131	n.g.	n.g.	31 vs 38
46	Phase 2	Etoposide, MTZ, AraC (EMA)	133	22/111	43	60 (REF: 44; REL: 76)
47	Phase 3, randomized	HiDAC + MTZ vs IDAC + MTZ	186	27/159	50	47 (REF <60 y: 46 vs 26)
58	Phase 3, randomized	HiDAC vs HiDAC + MTZ	162	56/106	48 vs 53	32 vs 44
59	Phase 3, randomized	Etoposide, MTZ, AraC (EMA) + GM-CSF vs EMA	192	120/72	47 vs 46	65 vs 59
59	Phase 3, randomized	Etoposide, MTZ, AraC (EMA) + GM-CSF vs EMA	192	120/72	47 vs 46	REF: 51 vs 46; REL: 89 vs 81
45	Phase 2	FLAG-IDA	46	10/36	41	52
60	Phase 2	Cladribine, HiDAC, MTZ	118	78/40	45	58 (REF:51; REL: 54)
61	Phase 2	FLAG-IDA ± GO	71	10/61	48	29 (+GO) vs 39 (−GO) (ORR 56 vs 52)
62	Phase 2, randomized	IDAC + GO vs IDAC + liposomal DNR vs AraC, CTX, topotecan	82	29/53	60 vs 52 vs 53	12 vs 7 vs 4
63	Phase 1/2	HiDAC + clofarabine + G-CSF	50 (46 eval.)	18/32	53	46 (ORR 61) (REL: 32; REF: 67)
64	Phase 2	IDAC + clofarabine	47	20/27	51	51 (REF: 45)
65	Phase 2	BIDFA ± GO	93	n.g.	62	23 (ORR: 27)
48	Phase 3, randomized	IDAC + clofarabine vs IDAC	326	171/148	67	35 vs 18 (ORR: 47 vs 23)
48	Phase 3, randomized	IDAC + clofarabine vs IDAC	326	171/148	67	REF: 46 vs 23; REL: 49 vs 23
66	Phase 2	Homoharringtonine, AraC, aclarubicine	46	11/35	37	80 (REF: 67; REL: 96)
67	Phase 3, randomized	SHAI vs SHAI + fludarabine IDAC + GO vs IDAC + liposomal DNR vs AraC, CTX, topotecan	326	n.g.	57 vs 52	35 vs 44 (ORR: 42 vs 54)
62	Phase 2, randomized		326	n.g.	57 vs 52	35 vs 44 (ORR: 42 vs 54)
28	Phase 2	Fludarabine, HiDAC, liposomal DNR MTZ, etoposide	41	11/30	60	0 vs 73
49	Phase 3, randomized	Elacytarabine vs others	381	140/241	59 vs 60	15 vs 12 (ORR: 23 vs 21)
50	Phase 2	CPX-351 vs first salvage therapy	125	125	52 vs 56	37.0 vs 31.8

Reference	Study design	Regimens	Number of patients	Refractory/ relapsed	Median age (y)	% CR
51	Phase 2	HiDAC vs HiDAC + DXR or DNR	78	42/36	37	63 vs 65 (REF: 20 vs 56)
52	Phase 2	MTZ, etoposide	61	21/20	47	43
53	Phase 2	MTZ, etoposide, IDAC (MEC)	32	18/14	24	66
54	Phase 2	MTZ, etoposide, IDAC (MEC)	74	0/30	37	55
55	Phase 2	IDAC + IDA + etoposide	97	36/61	37	43 (REF: 29)
56	Phase 3, randomized	MTZ, etoposide, AraC + G-CSF vs MTZ, etoposide, AraC	50	6/44	43 vs 47	54 vs 42
57	Phase 3, randomized	HiDAC vs HiDAC + etoposide	131	n.g.	n.g.	31 vs 38
46	Phase 2	Etoposide, MTZ, AraC (EMA)	133	22/111	43	60 (REF: 44; REL: 76)
47	Phase 3, randomized	HiDAC + MTZ vs IDAC + MTZ	186	27/159	50	47 (REF <60 y: 46 vs 26)
58	Phase 3, randomized	HiDAC vs HiDAC + MTZ	162	56/106	48 vs 53	32 vs 44
59	Phase 3, randomized	Etoposide, MTZ, AraC (EMA) + GM-CSF vs EMA	192	120/72	47 vs 46	65 vs 59
59	Phase 3, randomized	Etoposide, MTZ, AraC (EMA) + GM-CSF vs EMA	192	120/72	47 vs 46	REF: 51 vs 46; REL: 89 vs 81
45	Phase 2	FLAG-IDA	46	10/36	41	52
60	Phase 2	Cladribine, HiDAC, MTZ	118	78/40	45	58 (REF:51; REL: 54)
61	Phase 2	FLAG-IDA ± GO	71	10/61	48	29 (+GO) vs 39 (−GO) (ORR 56 vs 52)
62	Phase 2, randomized	IDAC + GO vs IDAC + liposomal DNR vs AraC, CTX, topotecan	82	29/53	60 vs 52 vs 53	12 vs 7 vs 4
63	Phase 1/2	HiDAC + clofarabine + G-CSF	50 (46 eval.)	18/32	53	46 (ORR 61) (REL: 32; REF: 67)
64	Phase 2	IDAC + clofarabine	47	20/27	51	51 (REF: 45)
65	Phase 2	BIDFA ± GO	93	n.g.	62	23 (ORR: 27)
48	Phase 3, randomized	IDAC + clofarabine vs IDAC	326	171/148	67	35 vs 18 (ORR: 47 vs 23)
48	Phase 3, randomized	IDAC + clofarabine vs IDAC	326	171/148	67	REF: 46 vs 23; REL: 49 vs 23
66	Phase 2	Homoharringtonine, AraC, aclarubicine	46	11/35	37	80 (REF: 67; REL: 96)
67	Phase 3, randomized	SHAI vs SHAI + fludarabine IDAC + GO vs IDAC + liposomal DNR vs AraC, CTX, topotecan	326	n.g.	57 vs 52	35 vs 44 (ORR: 42 vs 54)
62	Phase 2, randomized		326	n.g.	57 vs 52	35 vs 44 (ORR: 42 vs 54)
28	Phase 2	Fludarabine, HiDAC, liposomal DNR MTZ, etoposide	41	11/30	60	0 vs 73
49	Phase 3, randomized	Elacytarabine vs others	381	140/241	59 vs 60	15 vs 12 (ORR: 23 vs 21)
50	Phase 2	CPX-351 vs first salvage therapy	125	125	52 vs 56	37.0 vs 31.8

AraC, cytarabine; BIDFA, twice-daily fludarabine and cytarabine; CTX, cyclophosphamide; DNR, daunorubicin; DXR, doxorubicin; GO, gemtuzumab ozagamicin; HiDAC, high-dose cytarabine; IDAC, intermediate-dose cytarabine; MTZ, mitoxantron; ORR, overall response rate; REF, refractory; REL, relapsed; SHAI, sequential high-dose cytarabine + idarubicin.

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