Evidence map›Paper›PMID 23478060›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013

Phase III randomized study of rituximab/carmustine, etoposide, cytarabine, and melphalan (BEAM) compared with iodine-131 tositumomab/BEAM with autologous hematopoietic cell transplantation for relapsed diffuse large B-cell lymphoma: results from the BMT CTN 0401 trial.

Julie M Vose, Shelly Carter, Linda J Burns, Ernesto Ayala, Oliver W Press, Craig H Moskowitz, Edward A Stadtmauer, Shin Mineshi, Richard Ambinder, Timothy Fenske and 3 more

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

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00329030 (Phase III Rituxan/BEAM vs. Bexxar/BEAM With Autologous Hematopoietic Stem Cell Transplantation), which is not on this map. Cited by 65 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 5 pooled it
16.9field-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.

NCT00329030 phase3completednot on this map

Phase III Rituxan/BEAM vs. Bexxar/BEAM With Autologous Hematopoietic Stem Cell Transplantation (ASCT) for Persistent or Relapsed Chemotherapy Sensitive Diffuse Large B-cell Non-Hodgkin's Lymphoma (BMTCTN0401)

TypeinterventionalSponsorNational Heart, Lung, and Blood Institute (NHLBI)Ran2005 to 2013Enrolled224ConditionsLymphoma, B-Cell, Lymphoma, Large-Cell, Immunoblastic, Lymphoma, Non-HodgkinArmsAutologous transplantation using rituxan/BEAM, Autologous transplantation using Bexxar/BEAM
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 5 syntheses or guidelines pooled it, 176 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Cancer biotherapy & radiopharmaceuticals · 2020
    Trial
  9. Trial
  10. Updated Results of Rituximab Pre- and Post-BEAM with or withoutClinical cancer research : an official journal of the American Association for Cancer Research · 2018
    Trial
  11. Phase II Study of Yttrium-90 Ibritumomab Tiuxetan Plus High-Dose BCNU, Etoposide, Cytarabine, and Melphalan for Non-Hodgkin Lymphoma: The Role of Histology.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2017
    Trial
  12. Trial
  13. Trial
  14. Cytochrome P450 2B6*5 Increases Relapse after Cyclophosphamide-Containing Conditioning and Autologous Transplantation for Lymphoma.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2015
    Trial
  15. Trial
  16. Trial
  17. Review
  18. Article
  19. Review
  20. Review

5 more citing papers are in PubMed but not listed here.

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

13 authors at 1 institution in 1 country.

Julie M VoseSection of Hematology/Oncology, University of Nebraska Medical Center, Omaha, NE 68198-7680, USA. jmvose@unmc.edu
Shelly Carter
Linda J Burns
Ernesto Ayala
Oliver W Press
Craig H Moskowitz
Edward A Stadtmauer
Shin Mineshi
Richard Ambinder
Timothy Fenske
Mary Horowitz
Richard Fisher
Marcie Tomblyn
Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa · ZA

Funding

UNIVERSITY OF PENNSYLVANIA CAN CTR SUPPORT GRANTP30CA016520 · NCI · UNIVERSITY OF PENNSYLVANIA · PI SHELLEY L BERGER · 1985 to 2026
$222.3M
Data Resource for Analyzing Blood &Marrow TransplantsU24CA076518 · NCI · MEDICAL COLLEGE OF WISCONSIN · PI Amy M Moskop, Bronwen Shaw · 1998 to 2026
$105.2M
PB vs. BMU01HL069294 · NHLBI · MEDICAL COLLEGE OF WISCONSIN · PI HOROWITZ, MARY MARESCA · 2001 to 2010
$63.3M
Easy-to-read Informed Consent for HCT Clinical TrialsU10HL069294 · NHLBI · MEDICAL COLLEGE OF WISCONSIN · PI HOROWITZ, MARY MARESCA · 2011 to 2016
$43.8M
BMT CTN Core- University of Pennsylvania Abramson Cancer CenterUG1HL069286 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI Edward A Stadtmauer · 2017 to 2026
$2.0M
A Randomized Trial of Tac/MTX/bortezomib vs Tac/MTXplacebo in Allogeneic HSCTU10HL069249 · NHLBI · DANA-FARBER CANCER INST · PI ANTIN, JOSEPH H · 2011 to 2016
$1.1M
Bone Marrow Transplant Clinical NetworkU10HL069286 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI STADTMAUER, EDWARD A · 2011 to 2016
$986k
University of Michigan Core Clinical Center for BMT Research NetworkU10HL069330 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI YANIK, GREGORY A · 2011 to 2016
$959k
Enhancing the Safety of Allogeneic TransplantationU10HL069290 · NHLBI · UNIVERSITY OF MINNESOTA · PI WEISDORF, DANIEL J · 2011 to 2016
$931k
Case BMT CTN: Antibacterial Prophylaxis in Post-Engraftment Allogeneic HCTU10HL069348 · NHLBI · CASE WESTERN RESERVE UNIVERSITY · PI DE LIMA, MARCOS · 2011 to 2016
$902k
Core Clinical Consortium for Blood and Marrow Transplant Clinical Trials NetworkU10HL069301 · NHLBI · UNIVERSITY OF FLORIDA · PI WINGARD, JOHN R. · 2011 to 2016
$882k
Translational Research in Blood and Marrow TranslplantationU10HL069310 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI JONES, RICHARD J · 2011 to 2016
$777k
NCI NIH HHS P30 CA016520NCI NIH HHS U24 CA076518NHLBI NIH HHS U01 HL069294NHLBI NIH HHS U01HL069294NHLBI NIH HHS U10 HL069249NHLBI NIH HHS U10 HL069286NHLBI NIH HHS U10 HL069290NHLBI NIH HHS U10 HL069294NHLBI NIH HHS U10 HL069301NHLBI NIH HHS U10 HL069310NHLBI NIH HHS U10 HL069330NHLBI NIH HHS U10 HL069348NHLBI NIH HHS UG1 HL069286
6 · The paper itself

Abstract

purposeThis clinical trial evaluated standard-dose radioimmunotherapy with a chemotherapy-based transplantation regimen followed by autologous hematopoietic cell transplantation versus rituximab with the same regimen in patients with relapsed diffuse large B-cell lymphoma (DLBCL). PATIENTS AND

methodsPatients with chemotherapy-sensitive persistent or relapsed DLBCL were randomly assigned to receive iodine-131 tositumomab (dosimetric dose of 5 mCi on day -19 and therapeutic dose of 0.75 Gy on day -12), carmustine 300 mg/m(2) (day -6), etoposide 100 mg/m(2) twice daily (days -5 to -2), cytarabine 100 mg/m(2) twice daily (days -5 to -2), and melphalan 140 mg/m(2) (day -1; B-BEAM) or rituximab 375 mg/m(2) on days -19 and -12 and the same chemotherapy regimen (R-BEAM).

resultsTwo hundred twenty-four patients were enrolled, with 113 patients randomly assigned to R-BEAM and 111 patients assigned to B-BEAM. Two-year progression-free survival (PFS) rates, the primary end point, were 48.6% (95% CI, 38.6% to 57.8%) for R-BEAM and 47.9% (95% CI, 38.2% to 57%; P = .94) for B-BEAM, and the 2-year overall survival (OS) rates were 65.6% (95% CI, 55.3% to 74.1%) for R-BEAM and 61% (95% CI, 50.9% to 69.9%; P = .38) for B-BEAM. The 100-day treatment-related mortality rates were 4.1% (95% CI, 0.2% to 8.0%) for R-BEAM and 4.9% (95% CI, 0.8% to 9.0%; P = .97) for B-BEAM. The maximum mucositis score was higher in the B-BEAM arm (0.72) compared with the R-BEAM arm (0.31; P < .001).

conclusionThe B-BEAM and R-BEAM regimens produced similar 2-year PFS and OS rates for patients with chemotherapy-sensitive relapsed DLBCL. No differences in toxicities other than mucositis were noted.

Indexed as

AdolescentAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsCarmustineCombined Modality TherapyCytarabineEtoposideHematopoietic Stem Cell TransplantationHumansLymphoma, Large B-Cell, DiffuseMelphalanMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedCarmustineCytarabineEtoposideMelphalanRituximabtositumomab I-131

Identifiers

PMID23478060
PMCPMC3635682
OpenAlexW2097145287

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.