Evidence map›Paper›PMID 24127452›Full record

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

Disabling immune tolerance by programmed death-1 blockade with pidilizumab after autologous hematopoietic stem-cell transplantation for diffuse large B-cell lymphoma: results of an international phase II trial.

Philippe Armand, Arnon Nagler, Edie A Weller, Steven M Devine, David E Avigan, Yi-Bin Chen, Mark S Kaminski, H Kent Holland, Jane N Winter, James R Mason and 14 more

3 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
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 3 registered trials, which are not on this map. Cited by 218 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
218citing papers in PubMed, 8 pooled it
–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.

NCT02681302 phase1 / phase2terminatednot on this mapstarted 2016, after this paper: background citation

Phase Ib-IIA Study of Combined Check Point Inhibition After Autologous Hematopoietic Stem Cell Transplantation in Patients at High Risk for Post-transplant Recurrence

TypeinterventionalSponsorHackensack Meridian HealthRan2016 to 2024Enrolled46ConditionsMultiple Myeloma, LymphomaArmsIpilimumab, Nivolumab
NCT02846376 phase1terminatednot on this mapstarted 2019, after this paper: background citation

Phase I Study of Single-agent and Combined Checkpoint Inhibition After Allogeneic Hematopoietic Stem Cell Transplantation in Patients at High Risk for Post-transplant Recurrence

TypeinterventionalSponsorHackensack Meridian HealthRan2019 to 2023Enrolled8ConditionsAcute Myeloid Leukemia and Myelodysplastic SyndromeArmsNivolumab, Ipilimumab
NCT03605589 phase1withdrawnnot on this mapstarted 2018, after this paper: background citation

A Pilot Study of Blinatumomab in Combination With a PD1 Inhibitor, Pembrolizumab, in Pediatric and Young Adult Patients With Relapsed/Refractory CD19 Positive B-cell Acute Leukemia or Lymphoma

TypeinterventionalSponsorChildren's Hospital Medical Center, CincinnatiRan2018 to 2022Enrolled0ConditionsLeukemia, B-cell, Lymphoma, B-CellArmsBlinatumomab, Pembrolizumab
3 · Its place in the literature

Who cites it

218 citing papers in PubMed, 8 syntheses or guidelines pooled it.

  1. Pooled it
  2. Efficacy of nivolumab as checkpoint inhibitor drug on survival rate of patients with relapsed/refractory classical Hodgkin lymphoma: a meta-analysis of prospective clinical study.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2019
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Article
  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors.

Philippe ArmandPhilippe Armand and Edie Weller, Dana-Farber Cancer Institute; David E. Avigan, Beth Israel Deaconess Medical Center; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Arnon Nagler, Chaim Sheba Medical Center, Tel-Hashomer; Reuven Or, Hadassah Medical Center, Jerusalem; Rinat Rotem-Yehudar, CureTech, Yavne, Israel; Steven M. Devine, The Ohio State University Comprehensive Cancer Center, Ohio State University, Columbus; Hillard M. Lazarus, Case Western Reserve University and University Hospitals Case Medical Center, Cleveland, OH; Mark S. Kaminski, University of Michigan, Ann Arbor, MI; H. Kent Holland, Northside Hospital; Edmund K. Waller, Winship Cancer Institute, Emory University, Atlanta, GA; Jane N. Winter and Leo I. Gordon, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine; Stephanie A. Gregory, Rush Medical Center, Chicago, IL; James R. Mason, Scripps Clinic; Edward D. Ball, Moores University of California at San Diego Cancer Center, University of California, San Diego; John M. Timmerman and David Andorsky, University of California, Los Angeles, Los Angeles, CA; Joseph W. Fay, Baylor Research Institute, Baylor University Medical Center, Dallas; Chitra M. Hosing, The University of Texas MD Anderson Cancer Center, Houston, TX; David A. Rizzieri, Duke Cancer Center, Durham, NC; Joseph P. Uberti, Karmanos Cancer Institute, Detroit, MI; Markus Y. Mapara, University of Pittsburgh School of Medicine and Cancer Institute, Pittsburgh, PA.
Arnon Nagler
Edie A Weller
Steven M Devine
David E Avigan
Yi-Bin Chen
Mark S Kaminski
H Kent Holland
Jane N Winter
James R Mason
Joseph W Fay
David A Rizzieri
Chitra M Hosing
Edward D Ball
Joseph P Uberti
Hillard M Lazarus
Markus Y Mapara
Stephanie A Gregory
John M Timmerman
David Andorsky
Reuven Or
Edmund K Waller
Rinat Rotem-Yehudar
Leo I Gordon

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Trageting the Multiple Myeloma EpigenomeP50CA100707 · NCI · DANA-FARBER CANCER INSTITUTE · PI ANDERSON, KENNETH C., MUNSHI, NIKHIL C. · 2003 to 2023
$45.0M
Targeting Genomic Instability and Evolution in MyelomaP01CA155258 · NCI · DANA-FARBER CANCER INST · PI Jill Corre · 2011 to 2026
$32.5M
Targeting Myeloma Cell-Host Bone Marrow InteractionsP01CA078378 · NCI · DANA-FARBER CANCER INSTITUTE · PI RITZ, JEROME · 1998 to 2014
$26.2M
NCI NIH HHS P01 CA078378NCI NIH HHS P01 CA155258NCI NIH HHS P30 CA016672NCI NIH HHS P50 CA100707
6 · The paper itself

Abstract

purposeThe Programmed Death-1 (PD-1) immune checkpoint pathway may be usurped by tumors, including diffuse large B-cell lymphoma (DLBCL), to evade immune surveillance. The reconstituting immune landscape after autologous hematopoietic stem-cell transplantation (AHSCT) may be particularly favorable for breaking immune tolerance through PD-1 blockade. PATIENTS AND

methodsWe conducted an international phase II study of pidilizumab, an anti-PD-1 monoclonal antibody, in patients with DLBCL undergoing AHSCT, with correlative studies of lymphocyte subsets. Patients received three doses of pidilizumab beginning 1 to 3 months after AHSCT.

resultsSixty-six eligible patients were treated. Toxicity was mild. At 16 months after the first treatment, progression-free survival (PFS) was 0.72 (90% CI, 0.60 to 0.82), meeting the primary end point. Among the 24 high-risk patients who remained positive on positron emission tomography after salvage chemotherapy, the 16-month PFS was 0.70 (90% CI, 0.51 to 0.82). Among the 35 patients with measurable disease after AHSCT, the overall response rate after pidilizumab treatment was 51%. Treatment was associated with increases in circulating lymphocyte subsets including PD-L1E-bearing lymphocytes, suggesting an on-target in vivo effect of pidilizumab.

conclusionThis is the first demonstration of clinical activity of PD-1 blockade in DLBCL. Given these results, PD-1 blockade after AHSCT using pidilizumab may represent a promising therapeutic strategy in this disease.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalChileCombined Modality TherapyDisease-Free SurvivalDrug Administration ScheduleFatigueFemaleHematopoietic Stem Cell TransplantationHumansImmune ToleranceIndiaIsraelLymphocyte CountAntibodies, MonoclonalPDCD1 protein, humanpidilizumabProgrammed Cell Death 1 Receptor

Identifiers

PMID24127452
PMCPMC4878008

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.