Evidence map›Paper›PMID 38820500›Full record

Trial reportBlood2024

Randomized study of induction with bendamustine-rituximab ± bortezomib and maintenance with rituximab ± lenalidomide for MCL.

Mitchell R Smith, Opeyemi A Jegede, Peter Martin, Brian G Till, Samir S Parekh, David T Yang, Eric D Hsi, Thomas Witzig, Sandeep Dave, David Scott and 16 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Blood, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01415752 (Intergroup Randomized Phase 2 Four Arm Study In Patients ≥ 60 With Previously Untreated Mantle Cell Lymphoma Of Therapy With), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT01415752 phase2active not recruitingnot on this map

Intergroup Randomized Phase 2 Four Arm Study In Patients ≥ 60 With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB → R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV→ R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB → LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV → LR)

TypeinterventionalSponsorEastern Cooperative Oncology GroupRan2012 to 2031Enrolled373ConditionsLymphoma, Mantle Cell LymphomaArmsrituximab, Bendamustine, bortezomib, lenalidomide
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors.

Mitchell R SmithTaussig Cancer Institute, Cleveland Clinic, Cleveland, OH.ORCID 0000-0003-1428-8765
Opeyemi A JegedeDana Farber Cancer Institute, Boston, MA.ORCID 0000-0003-1763-8214
Peter MartinMeyer Cancer Center, Weill Cornell Medical College, NewYork-Presbyterian Hospital, New York, NY.
Brian G TillFred Hutchinson Cancer Center, Seattle, WA.
Samir S ParekhDivision of Hematology-Oncology, Icahn School of Medicine at Mount Sinai, New York, NY.
David T YangDepartment of Pathology and Laboratory Medicine, University of Wisconsin Carbone Cancer Center, Madison, WI.ORCID 0000-0002-9488-1704
Eric D HsiMayo Clinic, Rochester, MN.ORCID 0000-0001-8623-4067
Thomas WitzigMayo Clinic, Rochester, MN.ORCID 0000-0002-4215-6500
Sandeep DaveDepartment of Medicine, Duke University Medical Center, Durham, NC.
David ScottBC Cancer Agency-Vancouver Cancer Centre, Vancouver, BC, Canada.ORCID 0000-0002-0435-5947
Curtis HansonMayo Clinic, Rochester, MN.
Lale Kostakoglu ShieldsDepartment of Radiology, NYU Langone Health-Perlmutter Cancer Center, New York, NY.
Nizar Abdel-SamadThe Moncton Hospital, Moncton, NB, Canada.
Carla CasuloUniversity of Rochester Medical Center-James P. Wilmot Cancer Center, Rochester, NY.ORCID 0000-0003-4998-9932
Nancy L BartlettWashington University School of Medicine St. Louis and Siteman Cancer Center, St. Louis, MO.
Paolo F CaimiCase Comprehensive Cancer Center, Cleveland, OH.
Tareq Al BaghdadiSt. Joseph Mercy Hospital, Ann Arbor, MI.
Kristie A BlumThe Arthur G. James Comprehensive Cancer Center, The Ohio State University Wexner Medical Center, Columbus, OH.
Mark D RomerGood Samaritan Hospital-Dayton, Kettering, OH.
David J InwardsMayo Clinic, Rochester, MN.
Rachel E LernerFrauenshuh Cancer Center and Park Nicollet Institute, Minneapolis, MN.
Lynne I WagnerThe University of North Carolina at Chapel Hill, Chapel Hill, NC.ORCID 0000-0001-9685-4796
Richard F LittleCancer Therapy Evaluation Program, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0002-4091-1699
Jonathan W FriedbergUniversity of Rochester Medical Center-James P. Wilmot Cancer Center, Rochester, NY.
John P LeonardMeyer Cancer Center, Weill Cornell Medical College, NewYork-Presbyterian Hospital, New York, NY.
Brad S KahlWashington University School of Medicine St. Louis and Siteman Cancer Center, St. Louis, MO.ORCID 0000-0003-0459-6609

Funding

ECOG-ACRIN NCORP Research Base - TMISTUG1CA189828 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$199.7M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
Metro-Minnesota Community Oncology Research Consortium (MMCORC)UG1CA189863 · NCI · PARK NICOLLET INSTITUTE · PI JOLEEN M HUBBARD, Yan Ji · 2014 to 2026
$43.2M
ECOG-ACRIN Biospecimen Bank to Support NCTNU24CA196172 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI STANLEY R. HAMILTON, Scott D Jewell · 2015 to 2026
$41.1M
NCIC Clinical Trials Group - Canadian Collaborating Clinical Trials NetworkU10CA180863 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI Janet Ellen Dancey · 2014 to 2026
$40.4M
Michigan Cancer Research Consortium NCORPUG1CA189971 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI Tareq Al baghdadi · 2014 to 2026
$36.6M
WASHINGTON UNIVERSITY / SITEMAN CANCER CENTER LEAD ACADEMIC SITEUG1CA233339 · NCI · WASHINGTON UNIVERSITY · PI NANCY L BARTLETT, Clifford Grant Robinson · 2019 to 2026
$11.3M
Case Comprehensive Cancer Center NCTN Lead Academic Participating SiteUG1CA233234 · NCI · CASE WESTERN RESERVE UNIVERSITY · PI Aaron Thomas Gerds, Daniel Eidelberg Spratt · 2019 to 2026
$11.1M
Dayton Clinical Oncology ProgramUG1CA189957 · NCI · DAYTON CLINICAL ONCOLOGY PROGRAM · PI Howard M Gross · 2014 to 2026
$10.7M
NCI NIH HHS P01 CA214274NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180863NCI NIH HHS U10 CA180888NCI NIH HHS U24 CA196172NCI NIH HHS UG1 CA189828NCI NIH HHS UG1 CA189863NCI NIH HHS UG1 CA189957NCI NIH HHS UG1 CA189971NCI NIH HHS UG1 CA232760NCI NIH HHS UG1 CA233234NCI NIH HHS UG1 CA233253NCI NIH HHS UG1 CA233277NCI NIH HHS UG1 CA233320NCI NIH HHS UG1 CA233328NCI NIH HHS UG1 CA233331NCI NIH HHS UG1 CA233339
6 · The paper itself

Abstract

abstractAlthough initial therapy of mantle cell lymphoma (MCL) is not standardized, bendamustine plus rituximab (BR) is commonly used in older patients. Rituximab (R) maintenance after induction is often used. Thus, the open-label, randomized phase 2 ECOG-ACRIN Cancer Research Group E1411 trial was designed to test 2 questions: (1) does addition of bortezomib to BR induction (BVR) and/or (2) addition of lenalidomide to rituximab (LR) maintenance improve progression-free survival (PFS) in patients with treatment-naïve MCL? From 2012 to 2016, 373 previously untreated patients, 87% aged ≥60 years, were enrolled in this trial. At a median follow-up of 7.5 years, there is no difference in the median PFS of BR compared with BVR (5.5 vs 6.4 years; hazard ratio [HR], 0.90; 90% confidence interval [CI], 0.70-1.16). There were no unexpected additional toxicities with BVR treatment compared with BR, with no impact on total dose/duration of treatment received. Independent of the induction treatment, addition of lenalidomide did not significantly improve PFS, with median PFS in R vs LR (5.9 vs 7.2 years; HR, 0.84; 90% CI, 0.62-1.15). Most patients completed the planned 24 cycles of LR at the scheduled dose. In summary, adding bortezomib to BR induction does not prolong PFS in treatment-naïve MCL, and LR maintenance was not associated with longer PFS compared with R alone after BR. Nonetheless, the >5-year median PFS outcomes in this prospective cooperative group trial indicate the efficacy of BR followed by R maintenance as highly effective initial therapy for older patients with MCL. This trial was registered at www.clinicaltrials.gov as #NCT01415752.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBendamustine HydrochlorideBortezomibLenalidomideLymphoma, Mantle-CellMaintenance ChemotherapyRituximabAdultAgedAged, 80 and overFemaleHumansInduction ChemotherapyMaleMiddle AgedProgression-Free SurvivalBendamustine HydrochlorideBortezomibLenalidomideRituximab

Identifiers

PMID38820500
PMCPMC11561533

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.