Evidence map›Paper›PMID 23692856›Full record

Trial reportBlood2013

Ofatumumab in combination with ICE or DHAP chemotherapy in relapsed or refractory intermediate grade B-cell lymphoma.

Matthew J Matasar, Myron S Czuczman, Maria Alma Rodriguez, Michael Fennessy, Thomas C Shea, Gary Spitzer, Izidore S Lossos, Mohamed A Kharfan-Dabaja, Robin Joyce, Luis Fayad and 8 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Blood, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00823719 (A Single Arm, Safety and Efficacy Study of Ofatumumab in Combination With ICE or DHAP Chemotherapy in Relapsed or Refractory Aggressive Lymphoma Prior to Autologous Stem Cell Transplantation), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
8.1field-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.

NCT00823719 phase2completednot on this map

A Single Arm, Safety and Efficacy Study of Ofatumumab in Combination With ICE or DHAP Chemotherapy in Relapsed or Refractory Aggressive Lymphoma Prior to Autologous Stem Cell Transplantation

TypeinterventionalSponsorGlaxoSmithKlineRan2009 to 2011Enrolled61ConditionsLymphoma, Large-Cell, DiffuseArmsofatumumab + ICE, ofatumumab + DHAP
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 64 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. Three-Year Follow-Up of KTE-X19 in Patients With Relapsed/Refractory Mantle Cell Lymphoma, Including High-Risk Subgroups, in the ZUMA-2 Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Article
  11. Article
  12. Review
  13. The promise of CAR T-cell therapy in aggressive B-cell lymphoma.Best practice & research. Clinical haematology · 2018
    Review
  14. Anti-CD20 monoclonal antibodies: reviewing a revolution.Human vaccines & immunotherapeutics · 2018
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Diffuse large B-cell lymphoma: R-CHOP failure-what to do?Hematology. American Society of Hematology. Education Program · 2016
    Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 13 institutions in 3 countries.

Matthew J MatasarLymphoma and Adult Bone Marrow Transplant Services, Memorial Sloan-Kettering Cancer Center, New York, NY 10065, USA. matasarm@mskcc.org
Myron S Czuczman
Maria Alma Rodriguez
Michael Fennessy
Thomas C Shea
Gary Spitzer
Izidore S Lossos
Mohamed A Kharfan-Dabaja
Robin Joyce
Luis Fayad
Kristen Henkel
Qiming Liao
Klaus Edvardsen
Roxanne C Jewell
Doug Fecteau
Rajendra P Singh
Steen Lisby
Craig H Moskowitz
GlaxoSmithKline (United States) · USMemorial Sloan Kettering Cancer Center · USResearch Triangle Park Foundation · USThe University of Texas MD Anderson Cancer Center · USBeth Israel Deaconess Medical Center · USGenmab (Denmark) · DKGlaxoSmithKline (United Kingdom) · GBMoffitt Cancer Center · USPresbyterian Hospital · USRoswell Park Comprehensive Cancer Center · USSt. Francis Hospital · USUniversity of Miami · USUniversity of North Carolina at Chapel Hill · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

Standard treatment of transplant-eligible patients with relapsed diffuse large B-cell lymphoma (DLBCL) consists of rituximab and platinum-based chemotherapy, either ifosfamide, carboplatin, and etoposide (ICE) or dexamethasone, cytarabine, and cisplatin (DHAP), with autologous transplant consolidation for those with chemosensitive disease. Nonetheless, outcomes are suboptimal for patients failing rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). We performed a multi-center phase II trial investigating the safety and efficacy of ofatumumab, a monoclonal antibody against CD20, combined with ICE or DHAP second-line therapy in patients with relapsed or refractory DLBCL, grade 3b follicular lymphoma, or transformed follicular lymphoma. Sixty-one patients were treated with either ofatumumab-ICE (35) or ofatumumab-DHAP (26). The overall response rate (ORR) was 61%, and the complete response (CR) rate was 37%. In patients with 2 or 3 adverse risk factors according to the second-line, age-adjusted, international prognostic index, the ORR was 59% and CR 31%, and in patients with early-relapsing or primary refractory disease, the ORR was 55% and CR 30%. Toxicity was largely hematologic, and stem cell mobilization was successful in 43 of 45 patients. Substitution of ofatumumab for rituximab in standard second-line regimens following failure of R-CHOP is a promising approach. This trial was registered at www.clinicaltrials.gov as NCT00823719.

Indexed as

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCisplatinCytarabineDexamethasoneDrug Resistance, NeoplasmEtoposideFemaleHumansIfosfamideImmunotherapyLymphoma, B-CellAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCarboplatinCisplatinCytarabineDexamethasoneEtoposideIfosfamideofatumumab

Identifiers

PMID23692856
PMCPMC3724189
OpenAlexW2044947137

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.