Evidence map›Paper›PMID 23753028›Full record

Trial reportHaematologica2013

Rituximab plus gemcitabine and oxaliplatin in patients with refractory/relapsed diffuse large B-cell lymphoma who are not candidates for high-dose therapy. A phase II Lymphoma Study Association trial.

Nicolas Mounier, Taoufik El Gnaoui, Hervé Tilly, Danièle Canioni, Catherine Sebban, René-Olivier Casasnovas, Richard Delarue, Anne Sonet, Pauline Beaussart, Tony Petrella and 6 more

3 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Haematologica, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 68 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 4 pooled it
4.3field-weighted citation impact, top 6% 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.

NCT00169195 phase2completednot on this map

Gemcitabine-oxaliplatin Plus Rituximab (R-GEMOX) in Refractory/Relapsed Patients With CD 20 Positive Diffuse Large B-cell Lymphoma, Non Eligible for High-dose Chemotherapy Followed by Autotransplantation

TypeinterventionalSponsorLymphoma Study AssociationRan2003 to 2012Enrolled49ConditionsDiffuse Large Cell LymphomaArmsGemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)
NCT02758925 phase2unknown statusnot on this mapstarted 2016, after this paper: background citation

Phase 2 Study of Cytarabine in Association With Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B Cell Lymphoma

TypeinterventionalSponsorUniversity Hospital, CaenRan2016 to 2018Enrolled78ConditionsDiffuse Large B Cell LymphomaArmsRituximab, Bendamustine, Cytarabine
NCT05786989 phase4unknown statusnot on this mapstarted 2023, after this paper: background citation

Selinexor Combined With R-GemOx as Second-line Treatment in Patients With Diffuse Large B-cell Lymphoma: a Single-arm, Single-centre, Open-label Trial

TypeinterventionalSponsorChongqing University Cancer HospitalRan2023 to 2024Enrolled32ConditionsDiffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedArmsselinexor
3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 4 syntheses or guidelines pooled it, 170 citations in OpenAlex.

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8 more citing papers are in PubMed but not listed here.

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

16 authors at 8 institutions in 2 countries.

Nicolas Mouniercorinne.haioun@hmn.aphp.fr.
Taoufik El Gnaoui
Hervé Tilly
Danièle Canioni
Catherine Sebban
René-Olivier Casasnovas
Richard Delarue
Anne Sonet
Pauline Beaussart
Tony Petrella
Sylvie Castaigne
Serge Bologna
Gilles Salles
Alain Rahmouni
Philippe Gaulard
Corinne Haioun
Hôpital Necker-Enfants Malades · FRCentre Hospitalier Régional et Universitaire de Nancy · FRCentre Léon Bérard · FRCHU Dinant Godinne UCL Namur · BEHôpital André Mignot · FRHôpital l'Archet · FRHôpital Lyon Sud · FRLaboratoire National Henri Becquerel · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A previous pilot study with rituximab, gemcitabine and oxaliplatin showed promising activity in patients with refractory/relapsed B-cell lymphoma. We, therefore, conducted a phase II study to determine whether these results could be reproduced in a multi-institutional setting. This phase II study included 49 patients with refractory (n=6) or relapsing (n=43) diffuse large B-cell lymphoma. The median age of the patients was 69 years. Prior treatment included rituximab in 31 (63%) and autologous transplantation in 17 (35%) patients. International Prognostic Index at enrollment was >2 in 34 patients (71%). The primary endpoint was overall response rate after four cycles of treatment. Patients were planned to receive eight cycles if they reached at least partial remission after four cycles. After four cycles 21 patients (44%) were in complete remission and 8 (17%) in partial remission, resulting in an overall response rate of 61%. Factors significantly affecting overall response rate were early (<1 year) progression/relapse (18% versus 54%; P=0.001) and prior exposure to rituximab (23% versus 65%; P=0.004). Five-year progression-free and overall survival rates were 12.8% and 13.9%, respectively. Rituximab, gemcitabine and oxaliplatin were well tolerated with grade 3-4 infectious episodes in 22% of the cycles. These results are the first confirmation from a multicenter study that rituximab, gemcitabine and oxaliplatin provide a consistent response rate in patients with refractory/relapsed diffuse large B-cell lymphoma. This therapy can now be considered as a platform for new combinations with targeted treatments. This trial was registered at clinicaltrial.gov under #NCT00169195.

Indexed as

AdultAgedAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineFemaleFollow-Up StudiesGemcitabineHumansLymphoma, Large B-Cell, DiffuseMaleMiddle AgedOrganoplatinum CompoundsOxaliplatinRituximabSecondary PreventionAntibodies, Monoclonal, Murine-DerivedDeoxycytidineGemcitabineOrganoplatinum CompoundsOxaliplatinRituximab

Identifiers

PMID23753028
PMCPMC3815173
OpenAlexW2117460825

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.