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NATIONAL PEGASPARGASE-MODIFIED RISK-ORIENTED PROGRAM FOR PHILADELPHIA-NEGATIVE ADULT ACUTE LYMPHOBLASTIC LEUKEMIA/LYMPHOBLASTIC LYMPHOMA (PH− ALL/LL). GIMEMA LAL 1913 FINAL RESULTS.
Author(s): ,
Renato Bassan
Affiliations:
Hematology,Ospedale dell'Angelo,Venice,Italie;Hematology,Ospedale dell'Angelo,Venice,Italien;Hematology,Ospedale dell'Angelo,Venice,Italia;Hematology,Ospedale dell'Angelo,Venice,Italy;Hematology,Ospedale dell'Angelo,Venice,Italia;Hematology,Ospedale dell'Angelo,Venice,Italië;Hematology,Ospedale dell'Angelo,Venice,Itália;Hematology,Ospedale dell'Angelo,Venice,Италия;Hematology,Ospedale dell'Angelo,
,
Sabina Chiaretti
Affiliations:
Translational and Precision Medicine,Sapienza Univesrity of Rome,Rome,Italie;Translational and Precision Medicine,Sapienza Univesrity of Rome,Rome,Italien;Translational and Precision Medicine,Sapienza Univesrity of Rome,Rome,Italia;Translational and Precision Medicine,Sapienza Univesrity of Rome,Rome,Italy;Translational and Precision Medicine,Sapienza Univesrity of Rome,Rome,Italia;Translational a
,
Irene Della Starza
Affiliations:
Translational and Precision Medicine,Sapienza University of Rome,Rome,Italie;Translational and Precision Medicine,Sapienza University of Rome,Rome,Italien;Translational and Precision Medicine,Sapienza University of Rome,Rome,Italia;Translational and Precision Medicine,Sapienza University of Rome,Rome,Italy;Translational and Precision Medicine,Sapienza University of Rome,Rome,Italia;Translational a
,
Orietta Spinelli
Affiliations:
UOC Ematologia,ASST-Papa Giovanni XXIII,Bergamo,Italie;UOC Ematologia,ASST-Papa Giovanni XXIII,Bergamo,Italien;UOC Ematologia,ASST-Papa Giovanni XXIII,Bergamo,Italia;UOC Ematologia,ASST-Papa Giovanni XXIII,Bergamo,Italy;UOC Ematologia,ASST-Papa Giovanni XXIII,Bergamo,Italia;UOC Ematologia,ASST-Papa Giovanni XXIII,Bergamo,Italië;UOC Ematologia,ASST-Papa Giovanni XXIII,Bergamo,Itália;UOC Ematologia,
,
Alessandra Santoro
Affiliations:
Divisione di Ematologia con UTMO,Ospedali Riuniti Villa Sofia-Cervello,Palermo,Italie;Divisione di Ematologia con UTMO,Ospedali Riuniti Villa Sofia-Cervello,Palermo,Italien;Divisione di Ematologia con UTMO,Ospedali Riuniti Villa Sofia-Cervello,Palermo,Italia;Divisione di Ematologia con UTMO,Ospedali Riuniti Villa Sofia-Cervello,Palermo,Italy;Divisione di Ematologia con UTMO,Ospedali Riuniti Villa
,
Loredana Elia
Affiliations:
Translational and Precision Medicine,Sapienza University of Rome,Rome,Italie;Translational and Precision Medicine,Sapienza University of Rome,Rome,Italien;Translational and Precision Medicine,Sapienza University of Rome,Rome,Italia;Translational and Precision Medicine,Sapienza University of Rome,Rome,Italy;Translational and Precision Medicine,Sapienza University of Rome,Rome,Italia;Translational a
,
Maria Stefania De Propris
Affiliations:
Translational and Precision Medicine,Sapienza university of Rome,Rome,Italie;Translational and Precision Medicine,Sapienza university of Rome,Rome,Italien;Translational and Precision Medicine,Sapienza university of Rome,Rome,Italia;Translational and Precision Medicine,Sapienza university of Rome,Rome,Italy;Translational and Precision Medicine,Sapienza university of Rome,Rome,Italia;Translational a
,
Anna Maria Scattolin
Affiliations:
Hematology,Ospedale dell'Angelo,Venice,Italie;Hematology,Ospedale dell'Angelo,Venice,Italien;Hematology,Ospedale dell'Angelo,Venice,Italia;Hematology,Ospedale dell'Angelo,Venice,Italy;Hematology,Ospedale dell'Angelo,Venice,Italia;Hematology,Ospedale dell'Angelo,Venice,Italië;Hematology,Ospedale dell'Angelo,Venice,Itália;Hematology,Ospedale dell'Angelo,Venice,Италия;Hematology,Ospedale dell'Angelo,
,
Francesca Paoloni
Affiliations:
GIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli Onlus,Rome,Italie;GIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli Onlus,Rome,Italien;GIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli Onlus,Rome,Italia;GIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli Onlus,Rome,Italy;GIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli Onlus,Rome,Italia;GIMEMA Data Center,Fondazione GIMEM
,
Monica Messina
Affiliations:
GIIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli Onlus,Rome,Italie;GIIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli Onlus,Rome,Italien;GIIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli Onlus,Rome,Italia;GIIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli Onlus,Rome,Italy;GIIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli Onlus,Rome,Italia;GIIMEMA Data Center,Fondazione
,
Ernesta Audisio
Affiliations:
Ematologia,Città della Salute,Torino,Italie;Ematologia,Città della Salute,Torino,Italien;Ematologia,Città della Salute,Torino,Italia;Ematologia,Città della Salute,Torino,Italy;Ematologia,Città della Salute,Torino,Italia;Ematologia,Città della Salute,Torino,Italië;Ematologia,Città della Salute,Torino,Itália;Ematologia,Città della Salute,Torino,Италия;Ematologia,Città della Salute,Torino,Italien
,
Laura Marbello
Affiliations:
Hematology,Niguarda Ca' Granda Hospital,Milan,Italie;Hematology,Niguarda Ca' Granda Hospital,Milan,Italien;Hematology,Niguarda Ca' Granda Hospital,Milan,Italia;Hematology,Niguarda Ca' Granda Hospital,Milan,Italy;Hematology,Niguarda Ca' Granda Hospital,Milan,Italia;Hematology,Niguarda Ca' Granda Hospital,Milan,Italië;Hematology,Niguarda Ca' Granda Hospital,Milan,Itália;Hematology,Niguarda Ca' Grand
,
Erika Borlenghi
Affiliations:
Hematology, Spedali Civili, Brescia, Italy,Spedali Civili,Brescia,Italie;Hematology, Spedali Civili, Brescia, Italy,Spedali Civili,Brescia,Italien;Hematology, Spedali Civili, Brescia, Italy,Spedali Civili,Brescia,Italia;Hematology, Spedali Civili, Brescia, Italy,Spedali Civili,Brescia,Italy;Hematology, Spedali Civili, Brescia, Italy,Spedali Civili,Brescia,Italia;Hematology, Spedali Civili, Brescia
,
Patrizia Zappasodi
Affiliations:
Hematology,Foundation IRCCS Policlinico San Matteo,Pavia,Italie;Hematology,Foundation IRCCS Policlinico San Matteo,Pavia,Italien;Hematology,Foundation IRCCS Policlinico San Matteo,Pavia,Italia;Hematology,Foundation IRCCS Policlinico San Matteo,Pavia,Italy;Hematology,Foundation IRCCS Policlinico San Matteo,Pavia,Italia;Hematology,Foundation IRCCS Policlinico San Matteo,Pavia,Italië;Hematology,Found
,
Calogero Vetro
Affiliations:
General Surgery and Medical-Surgical Specialties,University of Catania,Catania,Italie;General Surgery and Medical-Surgical Specialties,University of Catania,Catania,Italien;General Surgery and Medical-Surgical Specialties,University of Catania,Catania,Italia;General Surgery and Medical-Surgical Specialties,University of Catania,Catania,Italy;General Surgery and Medical-Surgical Specialties,Univers
,
Giovanni Martinelli
Affiliations:
Institute of Hematology,L. and A. Seràgnoli,Bologna,Italie;Institute of Hematology,L. and A. Seràgnoli,Bologna,Italien;Institute of Hematology,L. and A. Seràgnoli,Bologna,Italia;Institute of Hematology,L. and A. Seràgnoli,Bologna,Italy;Institute of Hematology,L. and A. Seràgnoli,Bologna,Italia;Institute of Hematology,L. and A. Seràgnoli,Bologna,Italië;Institute of Hematology,L. and A. Seràgnoli,Bo
,
Daniele Mattei
Affiliations:
Hematology,Ospedale S. Croce, Cuneo, Italy,Cuneo,Italie;Hematology,Ospedale S. Croce, Cuneo, Italy,Cuneo,Italien;Hematology,Ospedale S. Croce, Cuneo, Italy,Cuneo,Italia;Hematology,Ospedale S. Croce, Cuneo, Italy,Cuneo,Italy;Hematology,Ospedale S. Croce, Cuneo, Italy,Cuneo,Italia;Hematology,Ospedale S. Croce, Cuneo, Italy,Cuneo,Italië;Hematology,Ospedale S. Croce, Cuneo, Italy,Cuneo,Itália;Hematolo
,
Nicola Fracchiolla
Affiliations:
UOC Oncoematologia,Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano,Milan,Italie;UOC Oncoematologia,Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano,Milan,Italien;UOC Oncoematologia,Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano,Milan,Italia;UOC Oncoematologia,Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano,Milan,Italy;
,
Monica Bocchia
Affiliations:
Hematology Unit,Azienda Ospedaliera Universitaria Senese,Siena,Italie;Hematology Unit,Azienda Ospedaliera Universitaria Senese,Siena,Italien;Hematology Unit,Azienda Ospedaliera Universitaria Senese,Siena,Italia;Hematology Unit,Azienda Ospedaliera Universitaria Senese,Siena,Italy;Hematology Unit,Azienda Ospedaliera Universitaria Senese,Siena,Italia;Hematology Unit,Azienda Ospedaliera Universitaria
,
Paolo De Fabritiis
Affiliations:
Hematology Division, S. Eugenio Hospital, Rome,Italie;Hematology Division, S. Eugenio Hospital, Rome,Italien;Hematology Division, S. Eugenio Hospital, Rome,Italia;Hematology Division, S. Eugenio Hospital, Rome,Italy;Hematology Division, S. Eugenio Hospital, Rome,Italia;Hematology Division, S. Eugenio Hospital, Rome,Italië;Hematology Division, S. Eugenio Hospital, Rome,Itália;Hematology Division, S
,
Massimiliano Bonifacio
Affiliations:
Ospedale Policlinico "G.B. Rossi",University of Verona,Verona,Italie;Ospedale Policlinico "G.B. Rossi",University of Verona,Verona,Italien;Ospedale Policlinico "G.B. Rossi",University of Verona,Verona,Italia;Ospedale Policlinico "G.B. Rossi",University of Verona,Verona,Italy;Ospedale Policlinico "G.B. Rossi",University of Verona,Verona,Italia;Ospedale Policlinico "G.B. Rossi",University of Verona,
,
Anna Candoni
Affiliations:
Clinica Ematologica,Azienda Sanitaria Universitaria Integrata di Udine,Udine,Italie;Clinica Ematologica,Azienda Sanitaria Universitaria Integrata di Udine,Udine,Italien;Clinica Ematologica,Azienda Sanitaria Universitaria Integrata di Udine,Udine,Italia;Clinica Ematologica,Azienda Sanitaria Universitaria Integrata di Udine,Udine,Italy;Clinica Ematologica,Azienda Sanitaria Universitaria Integrata di
,
Vincenzo Cassibba
Affiliations:
Divisione di Ematologia, Ospedale Civile,Bolzano,Italie;Divisione di Ematologia, Ospedale Civile,Bolzano,Italien;Divisione di Ematologia, Ospedale Civile,Bolzano,Italia;Divisione di Ematologia, Ospedale Civile,Bolzano,Italy;Divisione di Ematologia, Ospedale Civile,Bolzano,Italia;Divisione di Ematologia, Ospedale Civile,Bolzano,Italië;Divisione di Ematologia, Ospedale Civile,Bolzano,Itália;Division
,
Paolo Di Bartolomeo
Affiliations:
Oncology Hematology,Ospedale Civile,Pescara,Italie;Oncology Hematology,Ospedale Civile,Pescara,Italien;Oncology Hematology,Ospedale Civile,Pescara,Italia;Oncology Hematology,Ospedale Civile,Pescara,Italy;Oncology Hematology,Ospedale Civile,Pescara,Italia;Oncology Hematology,Ospedale Civile,Pescara,Italië;Oncology Hematology,Ospedale Civile,Pescara,Itália;Oncology Hematology,Ospedale Civile,Pescara
,
Giancarlo Latte
Affiliations:
Hematology,S. Franceso Hospital ,Nuoro,Italie;Hematology,S. Franceso Hospital ,Nuoro,Italien;Hematology,S. Franceso Hospital ,Nuoro,Italia;Hematology,S. Franceso Hospital ,Nuoro,Italy;Hematology,S. Franceso Hospital ,Nuoro,Italia;Hematology,S. Franceso Hospital ,Nuoro,Italië;Hematology,S. Franceso Hospital ,Nuoro,Itália;Hematology,S. Franceso Hospital ,Nuoro,Италия;Hematology,S. Franceso Hospital
,
Silvia Trappolini
Affiliations:
Clinica di Ematologia,Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I,Ancona,Italie;Clinica di Ematologia,Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I,Ancona,Italien;Clinica di Ematologia,Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I,Ancona,Italia;Clinica di Ematologia,Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I,Ancona,Italy;Clin
,
Anna Guarini
Affiliations:
Molecular Medicine,Sapienza University of Rome,Rome,Italie; Molecular Medicine,Sapienza University of Rome,Rome,Italien; Molecular Medicine,Sapienza University of Rome,Rome,Italia; Molecular Medicine,Sapienza University of Rome,Rome,Italy; Molecular Medicine,Sapienza University of Rome,Rome,Italia; Molecular Medicine,Sapienza University of Rome,Rome,Italië; Molecular Medicine,Sapienza University
,
Antonella Vitale
Affiliations:
Translational and Precision Medicine,Sapienza University of Rome,Rome,Italie;Translational and Precision Medicine,Sapienza University of Rome,Rome,Italien;Translational and Precision Medicine,Sapienza University of Rome,Rome,Italia;Translational and Precision Medicine,Sapienza University of Rome,Rome,Italy;Translational and Precision Medicine,Sapienza University of Rome,Rome,Italia;Translational a
,
Paola Fazi
Affiliations:
GIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli onlus,Rome,Italie;GIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli onlus,Rome,Italien;GIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli onlus,Rome,Italia;GIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli onlus,Rome,Italy;GIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli onlus,Rome,Italia;GIMEMA Data Center,Fondazione GIMEM
,
Marco Vignetti
Affiliations:
GIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli onlus,Rome,Italie;GIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli onlus,Rome,Italien;GIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli onlus,Rome,Italia;GIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli onlus,Rome,Italy;GIMEMA Data Center,Fondazione GIMEMA – Franco Mandelli onlus,Rome,Italia;GIMEMA Data Center,Fondazione GIMEM
,
Alessandro Rambaldi
Affiliations:
UOC Ematologia,ASST-Papa Giovanni XXIII,Bergamo,Italie;UOC Ematologia,ASST-Papa Giovanni XXIII,Bergamo,Italien;UOC Ematologia,ASST-Papa Giovanni XXIII,Bergamo,Italia;UOC Ematologia,ASST-Papa Giovanni XXIII,Bergamo,Italy;UOC Ematologia,ASST-Papa Giovanni XXIII,Bergamo,Italia;UOC Ematologia,ASST-Papa Giovanni XXIII,Bergamo,Italië;UOC Ematologia,ASST-Papa Giovanni XXIII,Bergamo,Itália;UOC Ematologia,
Robin Foà
Affiliations:
Translational and Precision Medicine,Sapienza university of ROme,Rome,Italie;Translational and Precision Medicine,Sapienza university of ROme,Rome,Italien;Translational and Precision Medicine,Sapienza university of ROme,Rome,Italia;Translational and Precision Medicine,Sapienza university of ROme,Rome,Italy;Translational and Precision Medicine,Sapienza university of ROme,Rome,Italia;Translational a
(Abstract release date: 05/12/22) EHA Library. Bassan R. 06/12/22; 356978; S113
Dr. Renato Bassan
Dr. Renato Bassan
Contributions
Abstract
Presentation during EHA2022: All Oral presentations will be presented between Friday, June 10 and Sunday, June 12 and will be accessible for on-demand viewing from Monday, June 20 until Monday, August 15, 2022 on the Congress platform.

Abstract: S113

Type: Oral Presentation

Session title: Novel insights into the treatment of ALL

Background
Pediatric-inspired chemotherapy is standard of care for younger adults with Ph− ALL/LL. An essential component of these regimens is pegaspargase, here incorporated into a national treatment program for patients 18-65 years.  

Aims
To assess in the GIMEMA Phase 2 LAL 1913 study the feasibility and efficacy of a pegaspargase-containing induction and consolidation regimen sustaining a risk-oriented strategy for adult Ph− ALL/LL (ClinicalTrials.gov ID NCT02067143).

Methods
Our prior, reference 8-block chemotherapy protocol (Blood Cancer J 2020;10:119) was modified to include pegaspargase 2000 IU/m2 at courses 1 (d10), 2 (d8), 5 (d3, with HD-MTX) and 6 (d8), with dose reductions in patients >55 years (pegaspargase 1000 IU/m2). Serum drug activity was not assessed in this study. Responders were risk-stratified for allogeneic stem cell transplantation (SCT) or maintenance according to a mixed risk model based on WBC count, immunophenotype, genetics and post-remission molecular minimal residual disease (MRD): patients with high-risk (HR) features or MRD ≥ 10-4 at weeks 10-16 or positive at week 22 were eligible to SCT; standard-risk (SR) patients were eligible to maintenance.  

Results
Two hundred and three patients entered the study (median age 39.8 years; 139 B- and 64 T-phenotype). The complete remission (CR) rate was 91% (100% in T-ALL/LL), with a 3-year cumulative relapse incidence and non-relapse mortality of 24.2% and 12.6%, respectively; 60 patients underwent a SCT. Overall (OS), event-free (EFS) and disease-free (DFS) survival were 66.7% (95% CI, 60.1-74.1%), 57.7% (95% CI, 51.0-65.3%) and 63.3% (95% CI, 56.3-71.1%) at 3 years. HR class (n=95) and LL diagnosis (n=20) did not affect prognosis. T-cell phenotype (CR 100%, P=0.001; EFS 67.1%, P=0.038), age 18-40 years (EFS 72.6%, P<0.0001) and MRD <10-4 after courses 1 (55%: DFS 77.9%, P=0.023) and 3 (79%: DFS 75.2%, P=0.048) were prognostically favorable. One hundred and eighty-seven patients had pegaspargase at course 1 (92.1%, 11 delayed, 3 reduced), 154 at course 2 (84.6%; 11 delayed, 12 reduced), 110 at course 5 (83.9%; 2 delayed, 11 reduced) and 73 at course 6 (68.8%; 3 delayed, 7 reduced). Dose reductions and delays were related to high-risk profile (liver dysfunction/steatosis, obesity etc.) or treatment toxicity.  Toxicity of grade 2 or more was mainly observed at course 1 (hepatic 12.8%, coagulation/thrombosis 3.2% [enoxaparin prophylaxis recommended with platelets >30-50], pancreatic 1.6%), contributing to an induction death in 3 patients (1.4%), but was rare afterwards. 

Conclusion
This pegaspargase-based ALL regimen was safely applicable to the majority of study patients, resulting in 3-year OS, EFS and DFS rates >50% in a patient population aged 18-65. The results were more favorable in patients up to the age of 55, especially in those aged 18-40 years, and in those who achieved maximum MRD response regardless of age (Figure). Subsequently, a pegaspargase dosing algorithm based on patient age, body mass index, hepatosteatosis and selected toxicities at first or prior drug exposure was developed to minimize toxicity, and was used in a successor GIMEMA trial of sequential chemotherapy-blinatumomab for CD19+ adult B-ALL (EHA Congress 2021, abstract S114).

Keyword(s): Acute lymphoblastic leukemia, Asparaginase, Minimal residual disease (MRD)

Presentation during EHA2022: All Oral presentations will be presented between Friday, June 10 and Sunday, June 12 and will be accessible for on-demand viewing from Monday, June 20 until Monday, August 15, 2022 on the Congress platform.

Abstract: S113

Type: Oral Presentation

Session title: Novel insights into the treatment of ALL

Background
Pediatric-inspired chemotherapy is standard of care for younger adults with Ph− ALL/LL. An essential component of these regimens is pegaspargase, here incorporated into a national treatment program for patients 18-65 years.  

Aims
To assess in the GIMEMA Phase 2 LAL 1913 study the feasibility and efficacy of a pegaspargase-containing induction and consolidation regimen sustaining a risk-oriented strategy for adult Ph− ALL/LL (ClinicalTrials.gov ID NCT02067143).

Methods
Our prior, reference 8-block chemotherapy protocol (Blood Cancer J 2020;10:119) was modified to include pegaspargase 2000 IU/m2 at courses 1 (d10), 2 (d8), 5 (d3, with HD-MTX) and 6 (d8), with dose reductions in patients >55 years (pegaspargase 1000 IU/m2). Serum drug activity was not assessed in this study. Responders were risk-stratified for allogeneic stem cell transplantation (SCT) or maintenance according to a mixed risk model based on WBC count, immunophenotype, genetics and post-remission molecular minimal residual disease (MRD): patients with high-risk (HR) features or MRD ≥ 10-4 at weeks 10-16 or positive at week 22 were eligible to SCT; standard-risk (SR) patients were eligible to maintenance.  

Results
Two hundred and three patients entered the study (median age 39.8 years; 139 B- and 64 T-phenotype). The complete remission (CR) rate was 91% (100% in T-ALL/LL), with a 3-year cumulative relapse incidence and non-relapse mortality of 24.2% and 12.6%, respectively; 60 patients underwent a SCT. Overall (OS), event-free (EFS) and disease-free (DFS) survival were 66.7% (95% CI, 60.1-74.1%), 57.7% (95% CI, 51.0-65.3%) and 63.3% (95% CI, 56.3-71.1%) at 3 years. HR class (n=95) and LL diagnosis (n=20) did not affect prognosis. T-cell phenotype (CR 100%, P=0.001; EFS 67.1%, P=0.038), age 18-40 years (EFS 72.6%, P<0.0001) and MRD <10-4 after courses 1 (55%: DFS 77.9%, P=0.023) and 3 (79%: DFS 75.2%, P=0.048) were prognostically favorable. One hundred and eighty-seven patients had pegaspargase at course 1 (92.1%, 11 delayed, 3 reduced), 154 at course 2 (84.6%; 11 delayed, 12 reduced), 110 at course 5 (83.9%; 2 delayed, 11 reduced) and 73 at course 6 (68.8%; 3 delayed, 7 reduced). Dose reductions and delays were related to high-risk profile (liver dysfunction/steatosis, obesity etc.) or treatment toxicity.  Toxicity of grade 2 or more was mainly observed at course 1 (hepatic 12.8%, coagulation/thrombosis 3.2% [enoxaparin prophylaxis recommended with platelets >30-50], pancreatic 1.6%), contributing to an induction death in 3 patients (1.4%), but was rare afterwards. 

Conclusion
This pegaspargase-based ALL regimen was safely applicable to the majority of study patients, resulting in 3-year OS, EFS and DFS rates >50% in a patient population aged 18-65. The results were more favorable in patients up to the age of 55, especially in those aged 18-40 years, and in those who achieved maximum MRD response regardless of age (Figure). Subsequently, a pegaspargase dosing algorithm based on patient age, body mass index, hepatosteatosis and selected toxicities at first or prior drug exposure was developed to minimize toxicity, and was used in a successor GIMEMA trial of sequential chemotherapy-blinatumomab for CD19+ adult B-ALL (EHA Congress 2021, abstract S114).

Keyword(s): Acute lymphoblastic leukemia, Asparaginase, Minimal residual disease (MRD)

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