Evidence map›Paper›PMID 37276451›Full record

ArticleBlood advances2023

Pegaspargase-modified risk-oriented program for adult acute lymphoblastic leukemia: results of the GIMEMA LAL1913 trial.

Renato Bassan, Sabina Chiaretti, Irene Della Starza, Orietta Spinelli, Alessandra Santoro, Francesca Paoloni, Monica Messina, Loredana Elia, Maria Stefania De Propris, Anna Maria Scattolin and 22 more

Registry-linked trialOpen access · goldAbstract readMulticenter Study
In one paragraph

Article in Blood advances, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02067143 (National Treatment Program of Philadelphia Chromosome-negative Adult Acute Lymphoblastic Leukemia With Pegylated Asparaginase Added to a Lineage-Targeted Risk- and Minimal Residual Disease-Oriented Strategy), which is not on this map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
7.8field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02067143 phase2completednot on this map

National Treatment Program of Philadelphia Chromosome-negative Adult Acute Lymphoblastic Leukemia With Pegylated Asparaginase Added to a Lineage-Targeted Risk- and Minimal Residual Disease-Oriented Strategy

TypeinterventionalSponsorGruppo Italiano Malattie EMatologiche dell'AdultoRan2014 to 2020Enrolled204ConditionsUntreated Philadelphia Positive Acute Lymphoblastic Leukemia, De Novo, Secondary, Low-dose Corticosteroids PretreatmentArmsPrephase PDN + CY, Cycle 1 Induction, Cycle 2 Induction / Early consolidation, Cycle 3 Early consolidation, Cycle 4 Consolidation
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 27 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

32 authors at 19 institutions in 1 country.

Renato BassanComplex Operational Unit of Hematology, Ospedale dell'Angelo, Mestre-Venezia, Italy.ORCID 0000-0001-8214-2894
Sabina ChiarettiDivision of Hematology, Department of Cellular Biotechnologies and Hematology, "Sapienza" University of Rome, Rome, Italy.
Irene Della StarzaDivision of Hematology, Department of Cellular Biotechnologies and Hematology, "Sapienza" University of Rome, Rome, Italy.
Orietta SpinelliComplex Structure of Hematology, AO Papa Giovanni XXIII, Bergamo; and Department of Oncology and Hematology, University of Milan, Milan, Italy.ORCID 0000-0003-0374-1536
Alessandra SantoroDivision of Hematology, Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy.
Francesca PaoloniCentro Dati Fondazione GIMEMA Franco Mandelli, Rome, Italy.
Monica MessinaCentro Dati Fondazione GIMEMA Franco Mandelli, Rome, Italy.
Loredana EliaDivision of Hematology, Department of Cellular Biotechnologies and Hematology, "Sapienza" University of Rome, Rome, Italy.
Maria Stefania De ProprisDivision of Hematology, Department of Cellular Biotechnologies and Hematology, "Sapienza" University of Rome, Rome, Italy.
Anna Maria ScattolinComplex Operational Unit of Hematology, Ospedale dell'Angelo, Mestre-Venezia, Italy.
Ernesta AudisioComplex Structure of Hematology, AO Città della Salute e della Scienza, Torino, Italy.
Laura MarbelloComplex Structure of Hematology, Ospedale Niguarda Ca' Granda, Milan, Italy.
Erika BorlenghiOperational Unit of Hematology, AO Spedali Civili, Brescia, Italy.
Patrizia ZappasodiComplex Structure of Hematology, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
Elisa MauroComplex Operational Unit of Hematology, AOU Policlinico S. Marco, University of Catania, Catania, Italy.
Giovanni MartinelliInstitute of Hematology "Seragnoli", Policlinico S. Orsola-Malpighi, University of Bologna, Bologna, Italy.
Daniele MatteiComplex Structure of Hematology, ASO S. Croce e Carle, Cuneo, Italy.ORCID 0000-0003-3152-4416
Nicola FracchiollaComplex Operational Unit of Onco-Hematology, Fondazione IRCCS Cà Granda Ospedale Maggiore, Milan, Italy.ORCID 0000-0002-8982-8079
Monica BocchiaComplex Operational Unit of Hematology, AO Senese Policlinico Le Scotte, Siena, Italy.ORCID 0000-0003-3538-3913
Paolo De FabritiisComplex Operational Unit of Hematology, Ospedale S. Eugenio ASL Roma 2, University of Tor Vergata, Rome, Italy.ORCID 0000-0002-1835-0581
Massimiliano BonifacioDepartment of Medicine, Complex Operational Unit of Hematology, Azienda Ospedaliera Universitaria Integrata, Verona, Italy.
Anna CandoniDepartment of Hematology, Azienda Ospedaliero-Universitaria, Udine, Italy.
Vincenzo CassibbaDivision of Hematology, Ospedale S. Maurizio, Bolzano, Italy.
Paolo Di BartolomeoOperational Unit of Clinical Hematology, Azienda USL, Pescara, Italy.
Giancarlo LatteSection of Clinical Hematology, Ospedale S. Francesco, Nuoro, Italy.
Silvia TrappoliniDepartment of Hematology, AOU Ospedali Riuniti, Ancona, Italy.
Anna GuariniDivision of Hematology, Department of Cellular Biotechnologies and Hematology, "Sapienza" University of Rome, Rome, Italy.
Antonella VitaleDivision of Hematology, Department of Cellular Biotechnologies and Hematology, "Sapienza" University of Rome, Rome, Italy.
Paola FaziCentro Dati Fondazione GIMEMA Franco Mandelli, Rome, Italy.
Alfonso PiciocchiCentro Dati Fondazione GIMEMA Franco Mandelli, Rome, Italy.ORCID 0000-0001-8648-885X
Alessandro RambaldiComplex Structure of Hematology, AO Papa Giovanni XXIII, Bergamo; and Department of Oncology and Hematology, University of Milan, Milan, Italy.
Robin FoàDivision of Hematology, Department of Cellular Biotechnologies and Hematology, "Sapienza" University of Rome, Rome, Italy.
Sapienza University of Rome · ITFondazione Gimema Onlus · ITOspedale dell' Angelo · ITUniversity of Milan · ITASL Roma · ITAzienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITAzienda Ospedaliera Universitaria Integrata Verona · ITAzienda Sanitaria Ospedaliera S.Croce e Carle Cuneo · ITAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITIRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · ITOspedale di Bolzano · ITOspedale Vincenzo Cervello · ITOspedali Riuniti di Ancona · ITPoliclinico San Matteo Fondazione · ITUniversity of Catania · ITUniversity of Modena and Reggio Emilia · ITUniversity of Siena · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pediatric-inspired chemotherapy is the standard of care for younger adults with Philadelphia chromosome-negative acute lymphoblastic leukemia/lymphoma (Ph- ALL/LL). In LAL1913 trial, the Gruppo Italiano Malattie EMatologiche dell'Adulto added pegaspargase 2000 IU/m2 to courses 1, 2, 5, and 6 of an 8-block protocol for patients aged from 18 to 65 years, with dose reductions in patients aged >55 years. Responders were risk stratified for allogeneic hematopoietic cell transplantation (HCT) or maintenance per clinical characteristics and minimal residual disease (MRD). Of 203 study patients (median age, 39.8 years), 91% achieved a complete remission. The 3-year overall survival, event-free, and disease-free survival (DFS) rates were 66.7%, 57.7%, and 63.3%, respectively, fulfilling the primary study end point of a 2-year DFS >55%. Although based on the intention-to-treat, the DFS being 74% and 50% in the chemotherapy (n = 94) and HCT (n = 91) assignment cohorts, respectively, a time-dependent analysis proved the value of HCT in patients who were eligible (DFS HCT 70% vs no HCT 26%; P <.0001). In multivariate analysis, age and MRD were independent factors predicting DFS rates of 86% (age ≤ 40 and MRD-negative), 64%-65% (MRD-positive or age > 40) and 25% (age > 40 and MRD-positive); P < .0001. Grade ≥2 pegaspargase toxicity was mainly observed at course 1, contributing to induction death in 2 patients but was rare thereafter. This program improved outcomes of patients with Ph- ALL/LL aged up to 65 years in a multicenter national setting. This trial was registered at www.clinicaltrials.gov as #NCT02067143.

Indexed as

Hematopoietic Stem Cell TransplantationPrecursor Cell Lymphoblastic Leukemia-LymphomaAcute DiseaseAdultAsparaginaseDisease-Free SurvivalHumansPolyethylene GlycolsRemission InductionAsparaginasepegaspargasePolyethylene Glycols

Identifiers

PMID37276451
PMCPMC10440455
OpenAlexW4379469503

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.