Evidence map›Paper›PMID 40990091›Full record

Trial reportAmerican journal of hematology2025

Real World Study on the Best CPX-351 Treatment Duration and Timing for Allogeneic Stem Cell Transplantation.

Fabio Guolo, Luana Fianchi, Maria Paola Martelli, Federico Lussana, Francesco Grimaldi, Federica Pilo, Michela Rondoni, Carla Filì, Paola Minetto, Debora Capelli and 47 more

Registry-linked trialAbstract readClinical Trial, Phase III
In one paragraph

Trial report in American journal of hematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01696084 (Phase III, Multicenter, Randomized, Trial of CPX-351), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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.

NCT01696084 phase3completednot on this map

Phase III, Multicenter, Randomized, Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients 60-75 Years of Age With Untreated High Risk (Secondary) AML

TypeinterventionalSponsorJazz PharmaceuticalsRan2012 to 2015Enrolled309ConditionsHigh Risk Acute Myeloid LeukemiaArmsCPX-351, 7+3 (cytarabine and daunorubicin)
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. AML, Myelodysplasia-Related: Beyond Classification-Toward Precision Decision-Making.Mediterranean journal of hematology and infectious diseases · 2026
    Review
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

57 authors.

Fabio GuoloUniversity of Genoa, Department of Internal Medicine (DiMI), Genoa, Italy.ORCID 0000-0003-3166-6078
Luana FianchiFondazione Policlinico Universitario "A. Gemelli" IRCCS, UOC Ematologia e TCSE, Rome, Italy.ORCID 0000-0002-7113-7202
Maria Paola MartelliUniversità di Perugia, Ospedale "Santa Maria della Misericordia", Dipartimento di Medicina e Chirurgia, Perugia, Italy.ORCID 0000-0001-9139-1729
Federico LussanaASST Papa Giovanni XXIII, Hematology and Bone Marrow Transplant Unit, Bergamo, Italy.ORCID 0000-0002-6510-8616
Francesco GrimaldiUniversità degli Studi di Napoli "Federico II", Naples, Italy.
Federica PiloOspedale Oncologico di Riferimento Regionale "Armando Businco", Hematology and Bone Marrow Transplantation Unit, Cagliari, Italy.
Michela RondoniHematology Unit and Metropolitan Romagna Transplant Network, Ravenna, Italy.
Carla FilìAzienda Sanitaria Universitaria Friuli Centrale (ASUFC), Division of Hematology and Stem Cell Transplantation, Udine, Italy.
Paola MinettoIRCCS Ospedale Policlinico San Martino, Dipartimento di Oncologia ed Ematologia, Genoa, Italy.ORCID 0000-0001-6094-4351
Debora CapelliAzienda Ospedaliera Universitaria Ospedali Riuniti di Ancona, Hematology Department, University of Ancona, Ancona, Italy.
Patrizia ChiusoloUniversita' Cattolica del Sacro Cuore, Department of Hematology, Rome, Italy.ORCID 0000-0002-1355-1587
Massimo BrecciaSapienza University, Department of Translational and Precision Medicine, Rome, Italy.ORCID 0000-0003-1163-6162
Sara MastaglioIstituto di Ricovero e Cura a Carattere Scientifico (IRCCS) san Raffaele Scientific Institute, Department of Onco-Hematology, Milan, Italy.
Massimo BernardiIstituto di Ricovero e Cura a Carattere Scientifico (IRCCS) san Raffaele Scientific Institute, Department of Onco-Hematology, Milan, Italy.
Monica BocchiaAzienda Ospedaliera Universitaria Senese, Hematology Unit, Siena, Italy.
Monica FumagalliOspedale "San Gerardo", ASST di Monza, SC Ematologia, Monza, Italy.
Sara GalimbertiUniversity of Pisa, Department of Clinical and Experimental Medicine, Section of Hematology, Pisa, Italy.
Valentina ManciniASST Grande Ospedale Metropolitano Niguarda, Niguarda Cancer Center, Department of Hematology, Milan, Italy.
Anna Lisa PiccioniSan Giovanni Hospital, Hematology, Rome, Italy.
Luca MaurilloUniversity Tor Vergata, Department of Biomedicine and Prevention, Hematology, Rome, Italy.ORCID 0000-0001-7297-4988
Nicola Stefano FracchiollaFondazione IRCCS ca' Granda-Ospedale Maggiore Policlinico, UOC Ematologia, Milan, Italy.ORCID 0000-0002-8982-8079
Raffaele PalmieriUniversity Tor Vergata, Department of Biomedicine and Prevention, Hematology, Rome, Italy.
Calogero VetroAOU Policlinico "G. Rodolico-San Marco", Divisione di Ematologia, Catania, Italy.ORCID 0000-0003-1922-5157
Cristina PapayannidisIRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli", Bologna, Italy.
Lorenzo BrunettiAzienda Ospedaliera Universitaria Ospedali Riuniti di Ancona, Hematology Department, University of Ancona, Ancona, Italy.
Alessandra SperottoVeneto Institute of Oncology IOV-IRCCS, Onco Hematology, Department of Oncology, Padua, Italy.ORCID 0000-0002-2762-4695
Federica GigliIRCCS Istituto Europeo di Oncologia, Divisione di Oncoematologia, Milan, Italy.
Patrizia ZappasodiFondazione IRCCS Policlinico "San Matteo", Dipartimento di Oncoematologia, Pavia, Italy.ORCID 0000-0001-9853-0592
Antonino MuléAzienda Ospedaliera Riunita (AOR) Villa Sofia-Vincenzo Cervello, Onco-Hematology Unit, Palermo, Italy.
Caterina PattiAzienda Ospedaliera Riunita (AOR) Villa Sofia-Vincenzo Cervello, Onco-Hematology Unit, Palermo, Italy.
Erika BorlenghiAO Spedali Civili, Operational Unit of Hematology, Brescia, Italy.ORCID 0000-0002-4666-3817
Michelina DargenioOspedale Vito Fazzi, Lecce, Italy.ORCID 0000-0003-0924-4629
Federica LessiUniversity of Padua, Department of Medicine, Hematology and Clinical Immunology Unit, Padua, Italy.
Marco CerranoAOU Città della Salute e della Scienza, Torino, Divisione di Ematologia, Dipartimento di Oncologia, Turin, Italy.ORCID 0000-0003-1666-3100
Daniela CilloniAO Ordine Mauriziano, SCDU Ematologia e Terapie Cellulari, Turin, Italy.ORCID 0000-0001-6346-4791
Alessandro IsidoriAORMN Hospital, Hematology and Stem Cell Transplant Center, Pesaro, Italy.ORCID 0000-0002-5723-9229
Monia LunghiAOU "Maggiore della Carità", SCDU Ematologia, Novara, Italy.
Caterina Alati"Bianchi-Melacrino-Morelli" Hospital, Hematology Unit, Hemato-Oncology and Radiotherapy Department, Reggio Calabria, Italy.
Carmela GurrieriUniversity of Padua, Department of Medicine, Hematology and Clinical Immunology Unit, Padua, Italy.
Carola RivaUniversity of Genoa, Department of Internal Medicine (DiMI), Genoa, Italy.ORCID 0009-0004-9649-6895
Giovanni MarconiHematology Unit and Metropolitan Romagna Transplant Network, Ravenna, Italy.ORCID 0000-0001-6309-0515
Ivana LotesoriereASST Valle Olona, Ospedale Di Busto Arsizio, Varese, Italy.
Samuele GataniASST Valle Olona, Ospedale Di Busto Arsizio, Varese, Italy.ORCID 0000-0003-4722-2527
Anna Maria ScattolinUnità Operativa di Ematologia, Ospedale dell'Angelo, Venezia, Italy.
Manuela CaizziS.C. Ematologia, Azienda Sanitaria Universitaria Integrata di Trieste, Trieste, Italy.
Salvatore PerroneDepartment of Hematology, Polo Universitario Pontino, S.M. Goretti Hospital, Latina, Italy.ORCID 0000-0001-8196-0481
Atto BillioOspedale di Bolzano, Bolzano, Italy.
Filippo GherlinzoniOspedale ca' Foncello, Treviso, Italy.
Francesco MannelliAzienda Ospedaliero-Universitaria Careggi, Hematology Department, Florence, Italy.ORCID 0000-0003-4810-6501
Michele GottardiVeneto Institute of Oncology IOV-IRCCS, Onco Hematology, Department of Oncology, Padua, Italy.
Roberto CairoliASST Grande Ospedale Metropolitano Niguarda, Niguarda Cancer Center, Department of Hematology, Milan, Italy.ORCID 0000-0001-6372-2623
Anna CandoniUniversità degli Studi di Modena e Reggio Emilia, Modena, Italy.
Felicetto FerraraAORN "A. Cardarelli", UOC Ematologia, Naples, Italy.ORCID 0000-0003-3721-5403
Livio PaganoFondazione Policlinico Universitario "A. Gemelli" IRCCS, UOC Ematologia e TCSE, Rome, Italy.ORCID 0000-0001-8287-928X
Roberto Massimo LemoliUniversity of Genoa, Department of Internal Medicine (DiMI), Genoa, Italy.
Adriano VendittiUniversity Tor Vergata, Department of Biomedicine and Prevention, Hematology, Rome, Italy.ORCID 0000-0002-0245-0553
Elisabetta TodiscoASST Valle Olona, Ospedale Di Busto Arsizio, Varese, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the registration clinical trial 301 (NCT01696084), CPX-351 has shown to be superior to conventional 3 + 7 in secondary AML (s-AML). However, the optimal duration of treatment, the best timing for allogeneic stem cell transplantation (allo-HSCT), and the activity of CPX-351 in specific s-AML subgroups are unclear. To evaluate these aspects, a total of 513 s-AML patients (median age 65.6 years, 19-79) treated with CPX-351 were retrospectively analyzed. Complete remission (CR) rate after induction was 297/513 (58%), increasing to 340/513 (66%) after cycle 2. Among the 340 responding patients, 118 (34.7%), 137 (40.3%), and 85 (25%) received none, one, or two consolidation cycles of CPX-351, respectively. Overall, 230/513 patients (48.8%) received allo-HSCT. Median follow up was 23.66 months and median overall survival (OS) was 16.23 months. Patients with mutated NPM1 or with ELN 2017 favorable risk (p < 0.05) had a significantly longer OS (p < 0.05). In a landmark analysis, receiving allo-HSCT was associated with a longer survival (Median OS not reached vs. 16.3 months for patients receiving or not receiving allo-HSCT, p < 0.05). Completion of all allowed CPX-351 cycles was beneficial only in patients not proceeding to transplant (p < 0.05), whereas in transplanted patients additional CPX-351 cycles did not improve outcome. Our analysis suggests that also s-AML patients with NPM1 mutations and those belonging to the ELN 2017 favorable risk category benefit from CPX-351. In eligible patients, allo-HSCT should be performed as soon as a CR is achieved, whereas patients not undergoing transplant benefit from a complete CPX-351 schedule.

Indexed as

Hematopoietic Stem Cell TransplantationLeukemia, Myeloid, AcuteAdultAgedCytarabineDaunorubicinFemaleHumansMaleMiddle AgedNuclear ProteinsNucleophosminRemission InductionRetrospective StudiesSurvival RateTime FactorsCPX-351CytarabineDaunorubicinNPM1 protein, humanNuclear ProteinsNucleophosminacute myeloid leukemiaallogeneic stem cell transplantationCPX‐351drug optimization

Identifiers

PMID40990091
PMCPMC12603885

What Socratic holds

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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 Socratic graph.