Evidence map›Paper›PMID 28945884›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2017

A phase II trial of lenalidomide plus rituximab in previously untreated follicular non-Hodgkin's lymphoma (NHL): CALGB 50803 (Alliance).

P Martin, S-H Jung, B Pitcher, N L Bartlett, K A Blum, T Shea, E D Hsi, J Ruan, S E Smith, J P Leonard and 1 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
8.3field-weighted citation impact, top 2% 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.

NCT01145495 phase2completednot on this map

A Phase II Trial of Lenalidomide (Revlimid (TM), CC-5013) (NSC #703813) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2010 to 2022Enrolled66ConditionsAnn Arbor Stage II Grade 1 Contiguous Follicular Lymphoma, Ann Arbor Stage II Grade 1 Non-Contiguous Follicular Lymphoma, Ann Arbor Stage II Grade 2 Contiguous Follicular Lymphoma, Ann Arbor Stage II Grade 2 Non-Contiguous Follicular LymphomaArmsLaboratory Biomarker Analysis, Lenalidomide, Rituximab
NCT07609446 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Pomalidomide Plus Anti-CD20 Antibody and Prednisone in Frontline Indolent B-Cell Lymphoma: A Prospective, Multicenter, Phase II Study

Typeobservational_patient_registrySponsorThe First Affiliated Hospital of Soochow UniversityRan2026 to 2027Enrolled30ConditionsIndolent Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Indolent Mantle Cell LymphomaArmsPomalidomide
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 81 citations in OpenAlex.

  1. Trial
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  8. Article
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  11. Six-Year Results From RELEVANCE: Lenalidomide Plus Rituximab (RJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Article
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  15. Treatment of indolent lymphoma.Blood research · 2022
    Review
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  19. Immunomodulatory Drugs for the Treatment of B Cell Malignancies.International journal of molecular sciences · 2021
    Review
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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

11 authors at 8 institutions in 1 country.

P MartinDepartment of Medicine, Weill Cornell Medicine, New York. Electronic address: pem9019@med.cornell.edu.
S-H JungAlliance Statistics and Data Center, Duke University Medical Center, Durham.
B PitcherAlliance Statistics and Data Center, Duke University Medical Center, Durham.
N L BartlettInternal Medicine, Division of Oncology, Washington University School of Medicine, St. Louis.
K A BlumThe Ohio State University Medical Center, Columbus.
T SheaOncology, University of North Carolina at Chapel Hill, Chapel Hill.
E D HsiClinical Pathology, Cleveland Clinic, Cleveland.
J RuanDepartment of Medicine, Weill Cornell Medicine, New York.
S E SmithAlliance Protocol Office, University of Chicago, Chicago.
J P LeonardDepartment of Medicine, Weill Cornell Medicine, New York.
B D ChesonHematology/Oncology, Georgetown University Hospital, Washington, USA.
Cornell University · USDuke Medical Center · USCleveland Clinic · USGeorgetown University · USThe Ohio State University Wexner Medical Center · USUniversity of Chicago · USUniversity of North Carolina at Chapel Hill · USWashington University in St. Louis · US

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$177.3M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
Heartland Cancer Research NCORPUG1CA189830 · NCI · DECATUR MEMORIAL HOSPITAL · PI Bryan A. Faller · 2014 to 2026
$40.9M
Southeast Clinical Oncology Research Consortium, Inc. (SCOR)UG1CA189858 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI Judith O Hopkins, William J Irvin · 2014 to 2026
$38.8M
Delaware Christiana Care NCORPUG1CA189819 · NCI · CHRISTIANA CARE HEALTH SERVICES, INC. · PI GREGORY A MASTERS · 2014 to 2026
$21.6M
VCU Massey Comprehensive Cancer Center NCI Community Oncology Research ProgramUG1CA189869 · NCI · VIRGINIA COMMONWEALTH UNIVERSITY · PI HARRY D BEAR, Khalid Matin · 2014 to 2026
$14.1M
Washington University/ Siteman Cancer Center Lead Academic SiteU10CA180833 · NCI · WASHINGTON UNIVERSITY · PI BARTLETT, NANCY L, KOZOWER, BENJAMIN D · 2014 to 2018
$7.6M
OSU as Network Lead Academic Participating Site for the NCI NCTNU10CA180850 · NCI · OHIO STATE UNIVERSITY · PI BLUM, KRISTIE A, CHAKRAVARTI, ARNAB · 2014 to 2018
$6.8M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareU10CA180867 · NCI · DANA-FARBER CANCER INST · PI BURSTEIN, HAROLD JOHN, KIBEL, ADAM S · 2014 to 2018
$6.2M
NCI National Clinical Trials Network-Network Lead Academic Participating SitesU10CA180836 · NCI · UNIVERSITY OF CHICAGO · PI CHMURA, STEVEN J, KINDLER, HEDY L · 2014 to 2018
$3.2M
NCTN Lead Academic Participating Sites ApplicationU10CA180838 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CAREY, LISA A · 2014 to 2018
$2.8M
NCI National Clinical Trials Network U10U10CA180857 · NCI · DUKE UNIVERSITY · PI BARBORIAK, DANIEL P, BRIZEL, DAVID M · 2014 to 2018
$2.0M
NCI NIH HHS U10 CA007968NCI NIH HHS U10 CA077597NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180833NCI NIH HHS U10 CA180836NCI NIH HHS U10 CA180838NCI NIH HHS U10 CA180850NCI NIH HHS U10 CA180857NCI NIH HHS U10 CA180867NCI NIH HHS U10 CA180882NCI NIH HHS UG1 CA189819NCI NIH HHS UG1 CA189830NCI NIH HHS UG1 CA189858NCI NIH HHS UG1 CA189869
6 · The paper itself

Abstract

backgroundThis multicenter, phase II trial tested the tolerability and efficacy of lenalidomide plus rituximab in patients with previously untreated follicular lymphoma (FL). PATIENTS AND

methodsPatients with grade 1-3a FL, stage 3-4 or bulky stage 2, FL international prognostic index (FLIPI) 0-2, and no prior therapy were eligible to receive rituximab 375 mg/m2 weekly during cycle 1 and day 1 of cycles 4, 6, 8, and 10, plus lenalidomide 20-25 mg on days 1-21 for twelve 28-day cycles. The primary objectives were to evaluate response rates [complete (CR) and overall] and time to progression. Secondary objectives included toxicity, response according to polymorphisms in FcgR2A and FcgR3A, and changes in circulating pro-angiogenic cells.

resultsFrom October 2010 to September 2011, 66 patients were enrolled. Median age was 53 years, 34 were female, 15 had bulky disease, 21 were FLIPI 0-1, 43 FLIPI 2, and 2 FLIPI 3. One patient withdrew before receiving treatment. Fifty-one patients completed 12 cycles of lenalidomide. Reasons for discontinuation included withdrawal (n = 6), adverse events (n = 6), progression (n = 2). Grade 3-4 hematologic toxicity included neutropenia (21%), lymphopenia (9%), and thrombocytopenia (2%), infection (11%), and rash (8%). Grade 1-2 toxicity included fatigue (78%), diarrhea (37%), rash (32%), and febrile neutropenia in one patient. The overall response rate was 95%; the CR rate was 72% (95% confidence interval, 60% to 83%). With a median follow-up of 5 years, the 2- and 5-year progression-free survival were 86% and 70%, respectively, and the 5-year overall survival was 100%. There was no association between CR rate or PFS and FLIPI, histological grade, bulky disease, FcgR2A/FcgR3A polymorphism, or change in circulating endothelial cell/hematopoietic progenitor cell.

conclusionLenalidomide plus rituximab was associated with low rates of grade 3-4 toxicity, yielded a CR rate and PFS similar to chemotherapy-based treatment and may represent a reasonable alternative to immunochemotherapy in previously untreated FL. CLINICALTRIALS.GOV IDENTIFIER: NCT01145495.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsFemaleFollow-Up StudiesHumansLenalidomideLymphoma, FollicularLymphoma, Non-HodgkinMaleMiddle AgedNeoplasm Recurrence, LocalPrognosisRituximabSurvival RateThalidomideLenalidomideRituximabThalidomidefollicular lymphomalenalidomiderituximab

Identifiers

PMID28945884
PMCPMC5789808
OpenAlexW2753889266

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.