Evidence map›Paper›PMID 37985359›Full record

Trial reportCancer2024

Safety and efficacy of ibrutinib in combination with rituximab and lenalidomide in previously untreated follicular and marginal zone lymphoma: An open label, phase 2 study.

Max J Gordon, Lei Feng, Paolo Strati, Hun Ju Lee, Fredrick B Hagemeister, Jason R Westin, Felipe Samaniego, Mario L Marques-Piubelli, Francisco Vega Vazquez, Edwin R Parra Cuentas and 13 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02532257 (An Open Label, Phase 2 Study of Ibrutinib in Combination With Rituximab and Lenalidomide in Previously Untreated Subjects With Follicular Lymphoma and Marginal Zone Lymphoma), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.8field-weighted citation impact, top 15% 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.

NCT02532257 phase2completednot on this map

An Open Label, Phase 2 Study of Ibrutinib in Combination With Rituximab and Lenalidomide in Previously Untreated Subjects With Follicular Lymphoma and Marginal Zone Lymphoma

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2016 to 2023Enrolled48ConditionsAnn Arbor Stage II Follicular Lymphoma, Ann Arbor Stage II Marginal Zone Lymphoma, Ann Arbor Stage III Follicular Lymphoma, Ann Arbor Stage III Marginal Zone LymphomaArmsIbrutinib, Laboratory Biomarker Analysis, Lenalidomide, Rituximab
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 1 institution in 1 country.

Max J GordonDepartment of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID 0000-0003-3940-4451
Lei FengDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Paolo StratiDepartment of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Hun Ju LeeDepartment of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Fredrick B HagemeisterDepartment of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Jason R WestinDepartment of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Felipe SamaniegoDepartment of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Mario L Marques-PiubelliDepartment of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID 0000-0002-6324-2096
Francisco Vega VazquezDivision of Pathology and Laboratory Medicine, Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Edwin R Parra CuentasDepartment of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Luisa M Solis-SotoDepartment of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Wencai MaDepartment of Bioinformatics and Computational Biology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Jing WangDepartment of Bioinformatics and Computational Biology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Linda ClaretDepartment of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Barbara AverillDepartment of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Karina IbanezDepartment of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Luis E FayadDepartment of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Christopher R FlowersDepartment of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID 0000-0002-9524-3990
Michael R GreenDepartment of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
R Eric DavisDepartment of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Sattva S NeelapuDepartment of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Nathan H FowlerDepartment of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Loretta J NastoupilDepartment of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
The University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DIANE BODURKA · 1985 to 2026
$290.8M
TRAINING FOR ACADEMIC ONCOLOGY/HEMATOLOGYT32CA009666 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Michael Davies, Courtney DiNardo · 1994 to 2026
$9.8M
NCI NIH HHS 5T32CA009666-27NCI NIH HHS CA16672NCI NIH HHS P30 CA016672NCI NIH HHS T32 CA009666
6 · The paper itself

Abstract

backgroundFollicular lymphoma (FL) and marginal zone lymphoma (MZL) are indolent non-Hodgkin lymphomas (iNHL). Median survival for iNHL is approximately 20 years. Because standard treatments are not curative, patients often receive multiple lines of therapy with associated toxicity-rationally designed, combination therapies with curative potential are needed. The immunomodulatory drug lenalidomide was evaluated in combination with rituximab for the frontline treatment of FL in the phase 3 RELEVANCE study. Ibrutinib, an oral Bruton tyrosine kinase inhibitor, is active in NHL and was evaluated in combination with lenalidomide, rituximab, and ibrutinib (IRR) in a phase 1 study.

methodsThe authors conducted an open-label, phase 2 clinical trial of IRR for previously untreated FL and MZL. The primary end point was progression-free survival (PFS) at 24 months.

resultsThis study included 48 participants with previously untreated FL grade 1-3a (N = 38), or MZL (N = 10). Participants received 12, 28-day cycles of lenalidomide (15 mg, days 1-21 cycle 1; 20 mg, cycles 2-12), rituximab (375 mg/m

conclusionsIRR is highly active as frontline therapy for FL and MZL. Compared to historical results with lenalidomide and rituximab, PFS is similar with higher grade 3-4 toxicity, particularly rash. The study was registered with ClinicalTrials.gov (NCT02532257).

Indexed as

ExanthemaLymphoma, B-Cell, Marginal ZoneLymphoma, FollicularPiperidinesAdenineAntineoplastic Combined Chemotherapy ProtocolsHumansLenalidomideRituximabAdenineibrutinibLenalidomidePiperidinesRituximabindolent lymphomanon-Hodgkin lymphoma (NHL)targeted therapy

Identifiers

PMID37985359
PMCPMC10922670
OpenAlexW4388851246

What OpenQuestion 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 OpenQuestion graph.