We designed a trial in which postremission therapy of young patients with de novo acute myeloid leukemia (AML) was decided combining cytogenetics/genetics and postconsolidation levels of minimal residual disease (MRD). After induction and consolidation, favorable-risk patients (FR) were to receive autologous stem cell transplant (AuSCT) and poor-risk patients (PR) allogeneic stem cell transplant (AlloSCT). Intermediate-risk patients (IR) were to receive AuSCT or AlloSCT depending on the postconsolidation levels of MRD. Three hundred sixty-one of 500 patients (72%) achieved a complete remission, 342/361 completed the consolidation phase and were treatment allocated: 165 (48%) to AlloSCT (122 PR, 43 IR MRD-positive) plus 23 rescued after salvage therapy, for a total of 188 candidates; 150 (44%) to AuSCT (115 FR, 35 IR MRD-negative) plus 27 IR patients (8%) with no leukemia-associated phenotype, for a total of 177 candidates. Overall, 110/177 (62%) and 130/188 (71%) AuSCT or AlloSCT candidates received it, respectively. Two-year overall (OS) and disease-free survival (DFS) of the whole series was 56% and 54%, respectively. Two-year OS and DFS were 74% and 61% in the FR category, 42% and 45% in the PR category, 79% and 61% in the IR MRD-negative category, and 70% and 67% in the IR MRD-positive category. In conclusion, AuSCT may still have a role in FR and IR MRD-negative categories. In the IR MRD-positive category, AlloSCT prolongs OS and DFS to equal those of the FR category. Using all the available sources of stem cells, AlloSCT was delivered to 71% of the candidates

GIMEMA AML1310 trial of risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia / Venditti, A.; Piciocchi, A.; Candoni, A.; Melillo, L.; Calafiore, V.; Cairoli, R.; De Fabritiis, P.; Storti, G.; Salutari, P.; Lanza, F.; Martinelli, G.; Luppi, M.; Mazza, P.; Martelli, M. P.; Cuneo, A.; Albano, F.; Fabbiano, F.; Tafuri, A.; Chierichini, A.; Tieghi, A.; Fracchiolla, N. S.; Capelli, D.; Foa, R.; Alati, C.; Sala, E. L.; Fazi, P.; Vignetti, M.; Maurillo, L.; Buccisano, F.; Del Principe, M. I.; Irno-Consalvo, M.; Ottone, T.; Lavorgna, S.; Voso, M. T.; Lo-Coco, F.; Arcese, W.; Amadori, S.. - In: BLOOD. - ISSN 0006-4971. - 134:12(2019), pp. 935-945. [10.1182/blood.2018886960]

GIMEMA AML1310 trial of risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia

Candoni A.;Luppi M.;
2019

Abstract

We designed a trial in which postremission therapy of young patients with de novo acute myeloid leukemia (AML) was decided combining cytogenetics/genetics and postconsolidation levels of minimal residual disease (MRD). After induction and consolidation, favorable-risk patients (FR) were to receive autologous stem cell transplant (AuSCT) and poor-risk patients (PR) allogeneic stem cell transplant (AlloSCT). Intermediate-risk patients (IR) were to receive AuSCT or AlloSCT depending on the postconsolidation levels of MRD. Three hundred sixty-one of 500 patients (72%) achieved a complete remission, 342/361 completed the consolidation phase and were treatment allocated: 165 (48%) to AlloSCT (122 PR, 43 IR MRD-positive) plus 23 rescued after salvage therapy, for a total of 188 candidates; 150 (44%) to AuSCT (115 FR, 35 IR MRD-negative) plus 27 IR patients (8%) with no leukemia-associated phenotype, for a total of 177 candidates. Overall, 110/177 (62%) and 130/188 (71%) AuSCT or AlloSCT candidates received it, respectively. Two-year overall (OS) and disease-free survival (DFS) of the whole series was 56% and 54%, respectively. Two-year OS and DFS were 74% and 61% in the FR category, 42% and 45% in the PR category, 79% and 61% in the IR MRD-negative category, and 70% and 67% in the IR MRD-positive category. In conclusion, AuSCT may still have a role in FR and IR MRD-negative categories. In the IR MRD-positive category, AlloSCT prolongs OS and DFS to equal those of the FR category. Using all the available sources of stem cells, AlloSCT was delivered to 71% of the candidates
2019
134
12
935
945
GIMEMA AML1310 trial of risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia / Venditti, A.; Piciocchi, A.; Candoni, A.; Melillo, L.; Calafiore, V.; Cairoli, R.; De Fabritiis, P.; Storti, G.; Salutari, P.; Lanza, F.; Martinelli, G.; Luppi, M.; Mazza, P.; Martelli, M. P.; Cuneo, A.; Albano, F.; Fabbiano, F.; Tafuri, A.; Chierichini, A.; Tieghi, A.; Fracchiolla, N. S.; Capelli, D.; Foa, R.; Alati, C.; Sala, E. L.; Fazi, P.; Vignetti, M.; Maurillo, L.; Buccisano, F.; Del Principe, M. I.; Irno-Consalvo, M.; Ottone, T.; Lavorgna, S.; Voso, M. T.; Lo-Coco, F.; Arcese, W.; Amadori, S.. - In: BLOOD. - ISSN 0006-4971. - 134:12(2019), pp. 935-945. [10.1182/blood.2018886960]
Venditti, A.; Piciocchi, A.; Candoni, A.; Melillo, L.; Calafiore, V.; Cairoli, R.; De Fabritiis, P.; Storti, G.; Salutari, P.; Lanza, F.; Martinelli, G.; Luppi, M.; Mazza, P.; Martelli, M. P.; Cuneo, A.; Albano, F.; Fabbiano, F.; Tafuri, A.; Chierichini, A.; Tieghi, A.; Fracchiolla, N. S.; Capelli, D.; Foa, R.; Alati, C.; Sala, E. L.; Fazi, P.; Vignetti, M.; Maurillo, L.; Buccisano, F.; Del Principe, M. I.; Irno-Consalvo, M.; Ottone, T.; Lavorgna, S.; Voso, M. T.; Lo-Coco, F.; Arcese, W.; Amadori, S.
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