Evidence map›Paper›PMID 35030036›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

Ibrutinib in Combination With Rituximab for Indolent Clinical Forms of Mantle Cell Lymphoma (IMCL-2015): A Multicenter, Open-Label, Single-Arm, Phase II Trial.

Eva Giné, Fátima de la Cruz, Ana Jiménez Ubieto, Javier López Jimenez, Alejandro Martín García-Sancho, M José Terol, Eva González Barca, María Casanova, Adolfo de la Fuente, Ana Marín-Niebla and 13 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02682641 (Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Ibrutinib in Combination With Rituximab in Patients With Indolent Clinical Forms of Mantle Cell Lymphoma), which is not on this map. Cited by 31 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 2 pooled it
8.4field-weighted citation impact, top 1% 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.

NCT02682641 phase2active not recruitingnot on this map

Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Ibrutinib in Combination With Rituximab in Patients With Indolent Clinical Forms of Mantle Cell Lymphoma

TypeinterventionalSponsorGrupo Español de Linfomas y Transplante Autólogo de Médula ÓseaRan2016 to 2029Enrolled50ConditionsMantle Cell LymphomaArmsIBRUTINIB, Rituximab
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 2 syntheses or guidelines pooled it, 58 citations in OpenAlex.

  1. Pooled it
  2. Efficacy and safety of ibrutinib in mantle cell lymphoma: A systematic review and meta-analysis.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2022
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Article
  10. Atrial fibrillation following bendamustine in three lymphoma patients.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2026
    Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Flow Cytometric MRD Detection in Selected Mature B-Cell Malignancies.Methods in molecular biology (Clifton, N.J.) · 2025
    Article
  18. Your chemo is no good here: management of high-risk MCL.Hematology. American Society of Hematology. Education Program · 2024
    Review
  19. Article
  20. Article
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

23 authors at 16 institutions in 1 country.

Eva GinéHematology Department, Hospital Clínic of Barcelona, Barcelona, Spain.ORCID 0000-0002-0532-1204
Fátima de la CruzHematology Department, Hospital Universitario Virgen del Rocio, Sevilla, Spain.
Ana Jiménez UbietoHematology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.
Javier López JimenezHematology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.ORCID 0000-0002-2969-3002
Alejandro Martín García-SanchoCentro de Investigación Biomédica en Red, Cáncer (CIBERONC), Madrid, Spain.ORCID 0000-0001-6330-1028
M José TerolHematology Department, Hospital Clínico de Valencia, Valencia, Spain.
Eva González BarcaHematology Department, Institut Català d'Oncologia, Hospital Duran i Reynals, Hospitalet de Llobregat, Spain.
María CasanovaHematology Department, Hospital Costa del Sol Marbella, Marbella, Spain.
Adolfo de la FuenteHematology Department, MD Anderson Cancer Center, Madrid, Spain.
Ana Marín-NieblaHematology Department, Hospital Universitari Vall d'Hebron, VHIO, Barcelona, Spain.ORCID 0000-0002-7592-6815
Ana MuntañolaHematology Department, Hospital Universitari Mútua Terrasa, Terrassa, Spain.
Tomás José González-LópezHematology Department, Hospital Universitario de Burgos, Burgos, Spain.
Marta AymerichInstitut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.ORCID 0000-0001-6286-7353
Xavier SetoainInstitut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.ORCID 0000-0002-0360-3240
Montserrat Cortés-RomeraNuclear Medicine Department, Hospital Universitari de Bellvitge, Hospitalet de Llobregat, Spain.
Amanda RotgerNuclear Medicine Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Sonia RodríguezUniversity of Barcelona, Barcelona, Spain.ORCID 0000-0002-1257-2757
Alejandro Medina HerreraCentro de Investigación Biomédica en Red, Cáncer (CIBERONC), Madrid, Spain.ORCID 0000-0001-5609-2969
Ramón García SanzCentro de Investigación Biomédica en Red, Cáncer (CIBERONC), Madrid, Spain.ORCID 0000-0003-4120-2787
Ferran NadeuInstitut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.ORCID 0000-0003-2910-9440
Silvia BeàInstitut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.ORCID 0000-0001-7192-2385
Elías CampoInstitut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.ORCID 0000-0001-9850-9793
Armando López-GuillermoHematology Department, Hospital Clínic of Barcelona, Barcelona, Spain.ORCID 0000-0002-8588-8381
Hospital Clínic de Barcelona · ESUniversidad de Salamanca · ESBellvitge University Hospital · ESBiomedical Research Networking Center in Bioengineering, Biomaterials and Nanomedicine · ESHospital Clínico Universitario de Valencia · ESHospital Costa del Sol · ESHospital General Universitario Gregorio Marañón · ESHospital Universitario 12 De Octubre · ESHospital Universitario de Burgos · ESHospital Universitario Ramón y Cajal · ESHospital Universitario Virgen del Rocío · ESInstitut Català d'Oncologia · ESInstituto de Investigación Biomédica de Salamanca · ESMD Anderson Cancer Center Madrid · ESMútua Terrassa · ESVall d'Hebron Hospital Universitari · ES

Funding

Preclinical Models and Therapeutics CoreP01CA229100 · NCI · MAYO CLINIC ARIZONA · PI SCOTT, DAVID WILLIAM · 2018 to 2022
$10.2M
NCI NIH HHS P01 CA229100
6 · The paper itself

Abstract

purposeThe need for an individualized management of indolent clinical forms in mantle cell lymphoma (MCL) is increasingly recognized. We hypothesized that a tailored treatment with ibrutinib in combination with rituximab (IR) could obtain significant responses in these patients.

methodsThis is a multicenter single-arm, open-label, phase II study with a two-stage design conducted in 12 Spanish GELTAMO sites (ClinicalTrials.gov identifier: NCT02682641). Previously untreated MCL patients with indolent clinical forms defined by the following criteria were eligible: no disease-related symptoms, nonblastoid variants, Ki-67 < 30%, and largest tumor diameter ≤ 3 cm. Both leukemic non-nodal and nodal subtypes were recruited. Patients received ibrutinib 560 mg once daily and a total of eight doses of rituximab 375 mg/m

resultsFifty patients with MCL (male 66%; median age 65 years) were enrolled. After 12 cycles of treatment, 42 (84%; 95% CI, 74 to 94) patients had an overall response, including 40 (80%; 95% CI, 69 to 91) with CR. Moreover, undetectable MRD in peripheral blood was achieved in 87% (95% CI, 77 to 97) of cases. At 2 years, 24 of 35 evaluable patients (69%) could discontinue ibrutinib because of undetectable MRD. Four patients had disease progression; three were non-nodal MCL and carried high genomic complexity and

conclusionFrontline IR combination achieves a high rate of CRs and undetectable MRD in indolent clinical forms of MCL. Discontinuation seems appropriate in cases with undetectable MRD, except for

Indexed as

Lymphoma, Mantle-CellAdenineAdultAgedAntineoplastic Combined Chemotherapy ProtocolsHumansMaleNeoplasm, ResidualPiperidinesRituximabAdenineibrutinibPiperidinesRituximab

Identifiers

PMID35030036
PMCPMC8987223
OpenAlexW4205380135

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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.