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.This trial was registered at www.clinicaltrials.gov as #NCT01452646 and EudraCT as #2010-023809-36.

Venditti, A., Piciocchi, A., Candoni, A., Melillo, L., Calafiore, V., Cairoli, R., et al. (2019). GIMEMA AML1310 trial of risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia. BLOOD, 134(12), 935-945 [10.1182/blood.2018886960].

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

Venditti, Adriano
;
de Fabritiis, Paolo;Buccisano, Francesco;Del Principe, Maria Ilaria;Irno-Consalvo, Maria;Ottone, Tiziana;Lavorgna, Serena;Voso, Maria Teresa;Lo-Coco, Francesco;Arcese, William;Amadori, Sergio
2019-09-19

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.This trial was registered at www.clinicaltrials.gov as #NCT01452646 and EudraCT as #2010-023809-36.
19-set-2019
Pubblicato
Rilevanza internazionale
Articolo
Esperti anonimi
Settore MED/15 - MALATTIE DEL SANGUE
English
acute myeloid leukemia Minimal Measurable Disease Risk-adapted therapy
Venditti, A., Piciocchi, A., Candoni, A., Melillo, L., Calafiore, V., Cairoli, R., et al. (2019). GIMEMA AML1310 trial of risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia. BLOOD, 134(12), 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, Mp; Cuneo, A; Albano, F; Fabbiano, F; Tafuri, A; Chierichini, A; Tieghi, A; Fracchiolla, Ns; Capelli, D; Foà, R; Alati, C; La Sala, E; Fazi, P; Vignetti, M; Maurillo, L; Buccisano, F; Del Principe, Mi; Irno-Consalvo, M; Ottone, T; Lavorgna, S; Voso, Mt; Lo-Coco, F; Arcese, W; Amadori, S
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/220032
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