Evidence map›Paper›PMID 40495420›Full record

Trial reportBritish journal of haematology2025

Copanlisib in combination with rituximab and bendamustine for transplant-ineligible relapsed/refractory diffuse large B-cell lymphoma patients: Results from the phase II multicentre FIL Copa-BR trial from Fondazione Italiana Linfomi (FIL).

Mattia Novo, Pio Manlio Mirko Frascione, Alessia Castellino, Luigi Marcheselli, Samantha Deianira Dattoli, Margherita Vannucchi, Delia Rota-Scalabrini, Alessandra Tucci, Guido Gini, Giuseppe Tarantini and 15 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of haematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
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

25 authors.

Mattia NovoSC Ematologia, AOU Città della Salute e della Scienza di Torino, Torino, Italy.ORCID https://orcid.org/0000-0002-5127-3653
Pio Manlio Mirko FrascioneCandiolo Cancer Institute, FPO-IRCCS, Candiolo (Torino), Italy.
Alessia CastellinoHematology Unit, Santa Croce e Carle Hospital, Cuneo, Italy.ORCID https://orcid.org/0000-0002-1922-9054
Luigi MarcheselliFondazione Italiana Linfomi, Modena, Italy.
Samantha Deianira DattoliFondazione Italiana Linfomi, Modena, Italy.
Margherita VannucchiPathology Unit, Department of Medical Biotechnology, University of Siena, Siena, Italy.
Delia Rota-ScalabriniCandiolo Cancer Institute, FPO-IRCCS, Candiolo (Torino), Italy.
Alessandra TucciDepartment of Hematology, ASST Spedali Civili, Brescia, Italy.
Guido GiniHematology, Department of Clinical and Molecular Sciences, Marche Polytechnic University, Ancona, Italy.ORCID https://orcid.org/0000-0002-5934-3943
Giuseppe TarantiniHaematology and BMT Unit, Monsignor R. Dimiccoli Hospital, Barletta, Italy.
Donato ManninaOncology-Hematology Department, Hematology Unit, Azienda Ospedaliera Papardo, Messina, Italy.
Annalisa ArcariHematology Unit, Guglielmo da Saliceto Hospital, Piacenza, Italy.ORCID https://orcid.org/0000-0001-5337-5947
Arcangelo LisoHematology/Oncology Unit, Terni Hospital, University of Perugia, Terni, Italy.
Elisabetta ScarpaHematology, Ca Foncello Hospital, Treviso, Italy.
Dario MarinoOncology 1 Unit, Department of Oncology, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy.
Michele SpinaDivision of Medical Oncology and Immune-Related Tumors, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.
Ausilia GorgoneUOC Ematologia ARNAS Garibaldi, Catania, Italy.
Nicola Di RenzoDepartment of Hematology and Stem Cell Transplant, Presidio Ospedaliero Vito Fazzi, Lecce, Italy.
Salvatrice MancusoHematology Unit, PROMISE Department, University of Palermo, Palermo, Italy.
Luigi PetrucciHematology, Department of Translational and Precision Medicine, Policlinico Umberto 1/Sapienza University of Rome, Rome, Italy.
Agostino TafuriHematology, University Hospital Sant'Andrea, Rome, Italy.
Barbara BottoSC Ematologia, AOU Città della Salute e della Scienza di Torino, Torino, Italy.
Francesca BonelloCandiolo Cancer Institute, FPO-IRCCS, Candiolo (Torino), Italy.
Elisa SantambrogioSC Ematologia, AOU Città della Salute e della Scienza di Torino, Torino, Italy.
Umberto VitoloCandiolo Cancer Institute, FPO-IRCCS, Candiolo (Torino), Italy.ORCID https://orcid.org/0000-0001-7772-2747

Funding

BayerFondazione Italiana LinfomiFPRC 5x1000 Ministero della Salute 2019 IDEE (WG5 RELAPS)FPRC 5x1000 Ministero della Salute 2021 EMAGENItalian Ministry of Health, Ricerca Corrente 2024-2025Sandoz
6 · The paper itself

Abstract

Treatment options for relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) patients ineligible for autologous stem cell transplant (ASCT) or chimeric antigen receptor (CAR)-T-cell therapy remain limited. The PI3K inhibitor copanlisib has shown activity as a single agent in DLBCL. This phase II, single-arm, multicentre trial evaluated copanlisib with rituximab and bendamustine (copa-BR) in ASCT- and CAR-T-ineligible R/R DLBCL. Patients received six cycles of copa-BR, followed by up to 12 cycles of copanlisib maintenance. The primary end-point was 12-month progression-free survival (PFS). Thirty-seven patients (aged 68-87 years, R/R after 1-2 prior lines) were enrolled. The overall response rate was 24.3%, with complete responses in 13.5%. After a median follow-up of 20 months, the 12-month PFS and overall survival rates were 25.1% and 44.5% respectively. Grade ≥3 toxicities included neutropenia (56.8%), infections (27.0%, including 6 death due to COVID-19 infection with 25% fatality) and thrombocytopenia (16.2%). Due to limited efficacy, poor tolerability and emerging alternative treatments, the trial was terminated prematurely. Copa-BR showed limited activity and an unfavourable safety profile, discouraging further investigation of this combination in ASCT- and CAR-T-ineligible R/R DLBCL.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsLymphoma, Large B-Cell, DiffuseAgedAged, 80 and overBendamustine HydrochlorideFemaleHumansMalePyrimidinesQuinazolinesRecurrenceRituximabBendamustine HydrochloridecopanlisibPyrimidinesQuinazolinesRituximabbendamustinecopanlisibdiffuse large B‐cell lymphomarelapsed/refractoryrituximab

Identifiers

PMID40495420
PMCPMC12378973

What Socratic holds

Textmetadata
LicenceCC BY-NC
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Registered trials

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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.