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 |
| 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.