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

Adriano Venditti, Alfonso Piciocchi, Anna Candoni, Lorella Melillo, Valeria Calafiore, Roberto Cairoli, Paolo De Fabritiis, Gabriella Storti, Prassede Salutari, Francesco Lanza, Giovanni Martinelli, Mario Luppi, Patrizio Mazza, Maria Paola Martelli, Antonio Cuneo, Francesco Albano, Francesco Fabbiano, Agostino Tafuri, Anna Chierichini, Alessia TieghiNicola Stefano Fracchiolla, Debora Capelli, Robin Foà, Caterina Alati, Edoardo La Sala, Paola Fazi, Marco Vignetti, Luca Maurillo, Francesco Buccisano, Maria Ilaria Del Principe, Maria Irno-Consalvo, Tiziana Ottone, Serena Lavorgna, Maria Teresa Voso, Francesco Lo-Coco, William Arcese, Sergio Amadori

Research output: Contribution to journalArticle

4 Citations (Scopus)

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

Original languageEnglish
Pages (from-to)935-945
Number of pages11
JournalBlood
Volume134
Issue number12
DOIs
Publication statusPublished - Sep 19 2019

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Residual Neoplasm
Acute Myeloid Leukemia
Young Adult
Transplants
Stem cells
Stem Cells
Therapeutics
Disease-Free Survival
Consolidation
Salvaging
Salvage Therapy

ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

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GIMEMA AML1310 trial of risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia. / Venditti, Adriano; Piciocchi, Alfonso; Candoni, Anna; Melillo, Lorella; Calafiore, Valeria; Cairoli, Roberto; De Fabritiis, Paolo; Storti, Gabriella; Salutari, Prassede; Lanza, Francesco; Martinelli, Giovanni; Luppi, Mario; Mazza, Patrizio; Martelli, Maria Paola; Cuneo, Antonio; Albano, Francesco; Fabbiano, Francesco; Tafuri, Agostino; Chierichini, Anna; Tieghi, Alessia; Fracchiolla, Nicola Stefano; Capelli, Debora; Foà, Robin; Alati, Caterina; Sala, Edoardo La; Fazi, Paola; Vignetti, Marco; Maurillo, Luca; Buccisano, Francesco; Del Principe, Maria Ilaria; Irno-Consalvo, Maria; Ottone, Tiziana; Lavorgna, Serena; Voso, Maria Teresa; Lo-Coco, Francesco; Arcese, William; Amadori, Sergio.

In: Blood, Vol. 134, No. 12, 19.09.2019, p. 935-945.

Research output: Contribution to journalArticle

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, Sala, EL, 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 2019, 'GIMEMA AML1310 trial of risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia', Blood, vol. 134, no. 12, pp. 935-945. https://doi.org/10.1182/blood.2018886960
Venditti, Adriano ; Piciocchi, Alfonso ; Candoni, Anna ; Melillo, Lorella ; Calafiore, Valeria ; Cairoli, Roberto ; De Fabritiis, Paolo ; Storti, Gabriella ; Salutari, Prassede ; Lanza, Francesco ; Martinelli, Giovanni ; Luppi, Mario ; Mazza, Patrizio ; Martelli, Maria Paola ; Cuneo, Antonio ; Albano, Francesco ; Fabbiano, Francesco ; Tafuri, Agostino ; Chierichini, Anna ; Tieghi, Alessia ; Fracchiolla, Nicola Stefano ; Capelli, Debora ; Foà, Robin ; Alati, Caterina ; Sala, Edoardo La ; Fazi, Paola ; Vignetti, Marco ; Maurillo, Luca ; Buccisano, Francesco ; Del Principe, Maria Ilaria ; Irno-Consalvo, Maria ; Ottone, Tiziana ; Lavorgna, Serena ; Voso, Maria Teresa ; Lo-Coco, Francesco ; Arcese, William ; Amadori, Sergio. / GIMEMA AML1310 trial of risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia. In: Blood. 2019 ; Vol. 134, No. 12. pp. 935-945.
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title = "GIMEMA AML1310 trial of risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia",
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",
author = "Adriano Venditti and Alfonso Piciocchi and Anna Candoni and Lorella Melillo and Valeria Calafiore and Roberto Cairoli and {De Fabritiis}, Paolo and Gabriella Storti and Prassede Salutari and Francesco Lanza and Giovanni Martinelli and Mario Luppi and Patrizio Mazza and Martelli, {Maria Paola} and Antonio Cuneo and Francesco Albano and Francesco Fabbiano and Agostino Tafuri and Anna Chierichini and Alessia Tieghi and Fracchiolla, {Nicola Stefano} and Debora Capelli and Robin Fo{\`a} and Caterina Alati and Sala, {Edoardo La} and Paola Fazi and Marco Vignetti and Luca Maurillo and Francesco Buccisano and {Del Principe}, {Maria Ilaria} and Maria Irno-Consalvo and Tiziana Ottone and Serena Lavorgna and Voso, {Maria Teresa} and Francesco Lo-Coco and William Arcese and Sergio Amadori",
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T1 - GIMEMA AML1310 trial of risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia

AU - Venditti, Adriano

AU - Piciocchi, Alfonso

AU - Candoni, Anna

AU - Melillo, Lorella

AU - Calafiore, Valeria

AU - Cairoli, Roberto

AU - De Fabritiis, Paolo

AU - Storti, Gabriella

AU - Salutari, Prassede

AU - Lanza, Francesco

AU - Martinelli, Giovanni

AU - Luppi, Mario

AU - Mazza, Patrizio

AU - Martelli, Maria Paola

AU - Cuneo, Antonio

AU - Albano, Francesco

AU - Fabbiano, Francesco

AU - Tafuri, Agostino

AU - Chierichini, Anna

AU - Tieghi, Alessia

AU - Fracchiolla, Nicola Stefano

AU - Capelli, Debora

AU - Foà, Robin

AU - Alati, Caterina

AU - Sala, Edoardo La

AU - Fazi, Paola

AU - Vignetti, Marco

AU - Maurillo, Luca

AU - Buccisano, Francesco

AU - Del Principe, Maria Ilaria

AU - Irno-Consalvo, Maria

AU - Ottone, Tiziana

AU - Lavorgna, Serena

AU - Voso, Maria Teresa

AU - Lo-Coco, Francesco

AU - Arcese, William

AU - Amadori, Sergio

PY - 2019/9/19

Y1 - 2019/9/19

N2 - 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

AB - 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

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