Evidence map›Paper›PMID 39808795›Full record

Trial reportBlood advances2025

Large clones of clonal hematopoiesis affect outcome in mantle cell lymphoma: results from the FIL MCL0208 clinical trial.

Simone Ragaini, Anna Galli, Elisa Genuardi, Martina Gandossini, Beatrice Alessandria, Aurora Maria Civita, Andrea Evangelista, Enrico Amaducci, Vittorio Stefoni, Federica Cavallo and 20 more

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

Trial report in Blood advances, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02354313 (A Phase III Multicenter, Randomized Study With Lenalidomide Maintenance vs Observation After Induction Regimen Containing Rituximab Followed by High Dose Chemotherapy and ASCT as First Line Treatment in Adult Patients With Advanced Mantle Cell Lymphoma), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT02354313 phase3unknown statusnot on this map

A Phase III Multicenter, Randomized Study With Lenalidomide Maintenance vs Observation After Induction Regimen Containing Rituximab Followed by High Dose Chemotherapy and ASCT as First Line Treatment in Adult Patients With Advanced Mantle Cell Lymphoma

TypeinterventionalSponsorFondazione Italiana Linfomi - ETSRan2010 to 2019Enrolled300ConditionsMANTLE CELL LYMPHOMAArmsLenalidomide
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. 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

30 authors.

Simone RagainiDepartment of Molecular Biotechnologies and Health, University of Torino, Torino, Italy.ORCID 0000-0003-3899-5755
Anna GalliDepartment of Hematology Oncology, IRCCS San Matteo Hospital Foundation, Pavia, Italy.ORCID 0000-0002-4039-3756
Elisa GenuardiDepartment of Molecular Biotechnologies and Health, University of Torino, Torino, Italy.ORCID 0000-0002-9624-0337
Martina GandossiniDepartment of Hematology Oncology, IRCCS San Matteo Hospital Foundation, Pavia, Italy.
Beatrice AlessandriaDepartment of Molecular Biotechnologies and Health, University of Torino, Torino, Italy.
Aurora Maria CivitaDepartment of Molecular Biotechnologies and Health, University of Torino, Torino, Italy.
Andrea EvangelistaUnit of Clinical Epidemiology, Azienda Ospedaliera Universitaria Città della Salute e della Scienza and Centro di Riferimento per l'Epidemiologia e la Prevenzione Oncologica in Piemonte, Torino, Italy.ORCID 0000-0003-1901-2805
Enrico AmaducciDepartment of Molecular Biotechnologies and Health, University of Torino, Torino, Italy.
Vittorio StefoniIRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli," Bologna, Italy.
Federica CavalloDepartment of Molecular Biotechnologies and Health, University of Torino, Torino, Italy.ORCID 0000-0003-2047-1099
Filippo BalleriniIRCCS Ospedale Policlinico San Martino, Genova, Italy.ORCID 0000-0001-8954-6752
Benedetta PucciniHematology Unit, Careggi University Hospital, Firenze, Italy.
Daniele VallisaHematology Unit, Department of Oncology and Hematology, Guglielmo da Saliceto Hospital, Piacenza, Italy.ORCID 0000-0002-3130-1979
Mariagrazia MichieliHigh Dose Chemotherapy and Cellular Therapies Unit, IRCCS Centro di Riferimento Oncologico di Aviano, Aviano, Italy.ORCID 0000-0001-6302-0488
Anna PascarellaHematology Unit, Ospedale dell'Angelo, Mestre-Venezia, Italy.ORCID 0000-0002-0984-5080
Angelo PalmasStruttura Complessa Ematologia, Ospedale San Francesco, Azienda Sanitaria Locale Nuoro, Nuoro, Italy.ORCID 0000-0002-0410-9754
Caterina PattiDepartment of Hematology I, Azienda Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy.
Elisa LucchiniUnità Complessa Operativa Ematologia, Azienda Sanitaria Universitaria Giuliano Isontina, Trieste, Italy.ORCID 0000-0002-4857-8325
Maria Grazia CaredduEmatologia, AOU Sassari, Sassari, Italy.
Michele MerliDipartimento di Oncologia ed Ematologia, Università degli Studi di Milano, Policlinico di Milano, Ospedale Maggiore, Fondazione IRCCS Ca Granda, Milano, Italy.
Massimiliano PostorinoHematology Unit, Department of Biomedicine and Prevention, University Tor Vergata, Roma, Italy.
Carola BoccominiStuttura Complessa Ematologia, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
Monica BalzarottiUnità Operativa di Ematologia, IRCCS Humanitas Research Hospital, Milano, Italy.ORCID 0000-0003-4666-5115
Vittorio Ruggero ZilioliDivision of Hematology, Azienda Socio-Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milano, Italy.
Maria Gomes da SilvaDepartment of Hematology, Portuguese Institute of Oncology, Lisbon, Portugal.ORCID 0000-0002-6993-2450
Benedetto BrunoDepartment of Molecular Biotechnologies and Health, University of Torino, Torino, Italy.ORCID 0000-0002-7299-6770
Ettore RizzoenGenome, Pavia, Italy.ORCID 0000-0003-1631-9000
Marco LadettoHematology, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.
Luca MalcovatiDepartment of Hematology Oncology, IRCCS San Matteo Hospital Foundation, Pavia, Italy.ORCID 0000-0002-1460-1611
Simone FerreroDepartment of Molecular Biotechnologies and Health, University of Torino, Torino, Italy.ORCID 0000-0002-9711-1502

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractAlthough recent evidence suggests that myeloid clonal hematopoiesis (M-CH) may influence lymphoma clinical outcome, its impact in mantle cell lymphoma (MCL) remains unclear. Here, we report a comprehensive next-generation sequencing-based analysis of the M-CH mutational landscape at baseline and follow-up in patients enrolled in the Fondazione Italiana Linfomi MCL0208 phase 3 trial, evaluating lenalidomide maintenance vs observation after chemoimmunotherapy and autologous stem cell transplantation (ASCT) in untreated young patients with MCL. Overall, 254 of 300 (85%) enrolled patients (median age, 57 years [range, 32-66]) had a baseline sample available for CH analysis. Using stringent criteria, at least 1 mutation involving M-CH candidate genes was described in 34 patients (13%), with DNMT3A being the most frequently mutated gene (54%). After a median follow-up of 7 years, the presence of large CH clones (variant allele frequency of ≥10%) predicted worse progression-free survival (hazard ratio [HR], 2.93; 95% confidence interval [CI] 1.36-6.31; P = .006) and overall survival (HR, 3.02 [1.21-7.55]; P = .018) compared with patients with CH. Importantly, the competing risks analysis demonstrates that the worse clinical outcome associated with M-CH large clones is linked to MCL progression (P < .05). Moreover, large M-CH clones showed longer time to hematological recovery after ASCT than the remaining cohort (P = .026). In conclusion, we showed for the first time that large CH clones might associate with unfavorable clinical impact in patients with MCL. This trial was registered at www.clinicaltrialsregister.eu as EudraCT (2009-012807-25) and www.ClinicalTrials.gov as #NCT02354313.

Indexed as

Clonal HematopoiesisLymphoma, Mantle-CellAdultAgedFemaleHematopoietic Stem Cell TransplantationHigh-Throughput Nucleotide SequencingHumansLenalidomideMaleMiddle AgedMutationTransplantation, AutologousTreatment OutcomeLenalidomide

Identifiers

PMID39808795
PMCPMC12008534

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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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.