Table 1.

Randomized trials of IL-2 monotherapy versus no treatment (standard-of-care) as remission maintenance in AML patients in CR1

Trial (NCT)*	n	Median follow-up (mo)	Age y	IL-2 regimen	Planned monthly dose (MIU/m2) × no. of mo	Results, IL-2 vs controls†	P, IL-2 vs controls
Blaise et al 200020	78	80	< 50	Cycle 1: 12 MIU/m2 QD × 5 days followed by 4 cycles of 2 days each	120 × 2	7-yr LFS: 30% vs 36% 7-yr OS: 38% vs 47%	LFS P = .54 OS P = .65
ALFA 980121	161	40	50-70	5 MIU/m2 QD × 5 d/mo	25 × 12	4-yr EFS‡: 28% vs 32%	EFS P = .88
						4-yr OS: 41% vs 47%	OS P = .14
CALGB 972022 (NCT00003190)	163	100	≥ 60	0.9 MIU/m2 QD × 10-14 days; followed by pulses of 12 MIU/m2 QD × 3 days between each 14-day cycle	82 × 3	No difference in median LFS = 6.1 months No difference in median OS = 14.7 months	LFS P = .47 OS P = .61
CALGB 1980823 (NCT00006363)	214	69	< 60	1 MIU/m2 QD × 10-14 days; followed by pulses of 12-15 MIU/m2 QD × 3 days between each 14-day cycle	91 × 3	3-yr LFS: 56% vs 45% 3-yr OS: 68% vs 61%	LFS P = .11 OS P = .09
CCG-296124 (NCT00002798)	289	54	≤ 21	9 MIU/m2 QD × 4 days then 1.6 MIU/m2 QD days 8-17 (14 infusions total)	52 × 0.6	5-yr LFS: 51% vs 58% 5-yr OS: 70% vs 73%	LFS P = .49 OS P = .73
EORTC-GIMEMA 699125 (NCT00004128)	550	43	< 61	2.3-4.6 MIU/m2 QD × 5 d/mo	12-24 × 12	3-yr LFS: 44% vs 42% 3-yr OS: 54% vs 56%	LFS P = .57 OS P = .94

AML indicates acute myeloid leukemia; LFS, leukemia-free survival; MIU, millions of international units; OS, overall survival; and QD, once daily.

^*ClinicalTrials.gov registry number if available.

^†IL-2 versus standard-of-care (no treatment).

^‡EFS calculated as the date from randomization to the date of CR achievement failure, first relapse, or death.