Evidence map›Paper›PMID 26970533›Full record

Trial reportBritish journal of haematology2016

Rituximab extended schedule or retreatment trial for low tumour burden non-follicular indolent B-cell non-Hodgkin lymphomas: Eastern Cooperative Oncology Group Protocol E4402.

Michael E Williams, Fangxin Hong, Randy D Gascoyne, Lynne I Wagner, John C Krauss, Thomas M Habermann, Lode J Swinnen, Stephen J Schuster, Christopher G Peterson, Mark D Sborov and 5 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in British journal of haematology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04508647 (Ublituximab as Initial Therapy for Treatment-naive Follicular or Marginal Zone Lymphoma With Response-driven Addition of Umbralisib for Suboptimal Response), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
4.2field-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.

NCT04508647 phase2completednot on this mapstarted 2020, after this paper: background citation

Ublituximab as Initial Therapy for Treatment-naive Follicular or Marginal Zone Lymphoma With Response-driven Addition of Umbralisib for Suboptimal Response

TypeinterventionalSponsorUniversity of Colorado, DenverRan2020 to 2022Enrolled4ConditionsMarginal Zone Lymphoma, Follicular LymphomaArmsUblituximab, Umbralisib
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Lenalidomide plus rituximab (RBritish journal of haematology · 2019
    Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Maintenance therapy for chronic lymphocytic leukaemia.The Cochrane database of systematic reviews · 2024
    Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Review
  19. Marginal Zone Lymphoma: State-of-the-Art Treatment.Current treatment options in oncology · 2019
    Review
  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

15 authors at 14 institutions in 2 countries.

Michael E WilliamsUniversity of Virginia Cancer Center, Charlottesville, VA, USA.
Fangxin HongDana Farber Cancer Institute, Boston, MA, USA.
Randy D GascoyneBritish Columbia Cancer Agency, Center for Lymphoid Cancer, Vancouver, BC, Canada.
Lynne I WagnerNorthwestern University, Chicago, IL, USA.
John C KraussUniversity of Michigan, Ann Arbor, MI, USA.
Thomas M HabermannMayo Clinic, Rochester, MN, USA.
Lode J SwinnenJohns Hopkins University, Baltimore, MD, USA.
Stephen J SchusterUniversity of Pennsylvania, Philadelphia, PA, USA.
Christopher G PetersonAspirus Regional Cancer Center, Wausau, WI, USA.
Mark D SborovFairview-Southdale Hospital, St. Louis Park, MN, USA.
S Eric MartinChristiana Care CCOP and the Helen F. Graham Cancer Network, Newark, DE, USA.
Matthias WeissMarshfield Clinic, Marshfield, WI, USA.
W Christopher EhmannPenn State Cancer Institute, Hershey, PA, USA.
Sandra J HorningGenentech, Inc., South San Francisco, CA, USA.
Brad S KahlWashington University School of Medicine, St. Louis, MO, USA.
Aspirus · USBC Cancer Agency · CAChristiana Care Health System · USDana-Farber Cancer Institute · USFairview Southdale Hospital · USJohns Hopkins University · USMarshfield Clinic · USMayo Clinic in Arizona · USNorthwestern University · USPenn State Milton S. Hershey Medical Center · USUniversity of Michigan–Ann Arbor · USUniversity of Pennsylvania · USUniversity of Virginia · USWashington University in St. Louis · US

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
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
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
ECOG Statistical Office Data Management GrantU10CA066636 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI GRAY, ROBERT J · 1994 to 2013
$39.5M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
MEDICAL CENTER OF DELAWARE CCOPU10CA045418 · NCI · CHRISTIANA CARE HEALTH SERVICES, INC. · PI GRUBBS, STEPHEN S. · 1987 to 2014
$14.5M
MARSHFIELD COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035412 · NCI · MARSHFIELD CLINIC RESEARCH FOUNDATION · PI REDING, DOUGLAS J · 1985 to 2014
$11.1M
EASTERN COOPERATIVE ONCOLOGY GROUP--WISCONSIN STUDIESU10CA021076 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI KAHL, BRAD · 1985 to 2013
$8.2M
Washington University/ Siteman Cancer Center Lead Academic SiteU10CA180833 · NCI · WASHINGTON UNIVERSITY · PI BARTLETT, NANCY L, KOZOWER, BENJAMIN D · 2014 to 2018
$7.6M
ECOG Clinical TrialsU10CA017145 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI BENSON, AL B · 1985 to 2013
$6.1M
NCI NIH HHS U10 CA013650NCI NIH HHS U10 CA015488NCI NIH HHS U10 CA016116NCI NIH HHS U10 CA017145NCI NIH HHS U10 CA021076NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA035412NCI NIH HHS U10 CA045418NCI NIH HHS U10 CA049957NCI NIH HHS U10 CA066636NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180802NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180833NCI NIH HHS U10 CA180847NCI NIH HHS U24 CA196172NCI NIH HHS UG1 CA189828NCI NIH HHS UG1 CA233196NCI NIH HHS UG1 CA233270
6 · The paper itself

Abstract

The rituximab extended schedule or retreatment trial (RESORT; E4402) was a phase 3 randomized prospective trial comparing maintenance rituximab (MR) versus a retreatment (RR) dosing strategy in asymptomatic, low tumour burden indolent lymphoma. A planned exploratory sub-study compared the two strategies for small lymphocytic (SLL) and marginal zone lymphomas (MZL). Patients responding to rituximab weekly × 4 were randomized to MR (single dose rituximab every 3 months until treatment failure) or RR (rituximab weekly × 4) at the time of each progression until treatment failure. The primary endpoint was time to treatment failure (TTTF). Patients with SLL (n = 57), MZL (n = 71) and unclassifiable small B-cell lymphoma (n = 3) received induction rituximab. The overall response rate (ORR) was 40% [95% confidence interval (CI) 31-49%; SLL ORR 22·8%; MZL ORR 52·1%]; all 52 responders were randomized. At a median of 4·3 years from randomization, treatment failure occurred in 18/23 RR and 15/29 MR. The median TTTF was 1·4 years for RR and 4·8 years for MR (P = 0·012); median time to first cytotoxic therapy was 6·3 years for RR and not reached for MR (P = 0·0002). Survival did not differ (P = 0·72). In low tumour burden SLL and MZL patients responding to rituximab induction, MR significantly improved TTTF as compared with RR.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsDrug Administration ScheduleFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellLymphoma, B-CellLymphoma, B-Cell, Marginal ZoneMaleMiddle AgedRemission InductionRetreatmentRituximabTreatment FailureAntineoplastic AgentsRituximabB-cell lymphomaindolent lymphomamaintenancerituximab

Identifiers

PMID26970533
PMCPMC4900920
OpenAlexW2292975070

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.