Evidence map›Paper›PMID 34771451›Full record

ArticleCancers2021

Risk, Characteristics and Biomarkers of Cytokine Release Syndrome in Patients with Relapsed/Refractory AML or MDS Treated with CD3xCD123 Bispecific Antibody APVO436.

Fatih M Uckun, Justin Watts, Alice S Mims, Prapti Patel, Eunice Wang, Paul J Shami, Elizabeth Cull, Cynthia Lee, Christopher R Cogle, Tara L Lin

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Cancers, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03647800 (Phase 1B Open-Label, Dose-Escalation and Dose-Expansion Study of APVO436 in Patients With Relapsed or Refractory Acute Myeloid Leukemia), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.6field-weighted citation impact, top 28% 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.

NCT03647800 phase1unknown statusnot on this map

Phase 1B Open-Label, Dose-Escalation and Dose-Expansion Study of APVO436 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or High-Grade Myelodysplastic Syndrome (MDS)

TypeinterventionalSponsorAptevo Research and Development LLCRan2018 to 2023Enrolled136ConditionsAML, MDSArmsAPVO436
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Article
  5. Review
  6. Frontiers in oncology · 2021
    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

10 authors at 9 institutions in 1 country.

Fatih M UckunDepartment of Regulatory Affairs and Clinical Research, Aptevo Therapeutics, Seattle, WA 98121, USA.ORCID 0000-0001-9334-183X
Justin WattsDivision of Hematology, Department of Medicine, Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL 33136, USA.
Alice S MimsThe James Cancer Hospital, The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA.
Prapti PatelHarold C. Simmons Comprehensive Cancer Center, Department of Internal Medicine, Division of Hematology-Oncology, University of Texas Southwestern Medical Center, Dallas, TX 75390, USA.
Eunice WangRoswell Park Comprehensive Cancer Center, Department of Medicine, Buffalo, NY 14263, USA.
Paul J ShamiDivision of Hematology and Hematologic Malignancies, Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT 84112, USA.
Elizabeth CullGreenville Health System, Institute for Translational Oncology Research, Greenville, SC 29605, USA.
Cynthia LeeDepartment of Regulatory Affairs and Clinical Research, Aptevo Therapeutics, Seattle, WA 98121, USA.
Christopher R CogleDepartment of Medicine, Division of Hematology & Oncology, University of Florida, Gainesville, FL 32610, USA.ORCID 0000-0001-5422-6863
Tara L LinDivision of Hematologic Malignancies and Cellular Therapeutics, The University of Kansas Cancer Center, Westwood, KS 66205, USA.
Aptevo Therapeutics (United states) · USPrisma Health · USRoswell Park Comprehensive Cancer Center · USThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · USThe University of Kansas Cancer Center · USThe University of Texas Southwestern Medical Center · USUniversity of Florida · USUniversity of Miami · USUniversity of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We evaluate the risk, characteristics and biomarkers of treatment-emergent cytokine release syndrome (CRS) in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who received APVO436 during the dose-escalation phase of a Phase 1B study (ClinicalTrials.gov, identifier: NCT03647800). Of four patients who developed Grade ≥ 3 CRS, two received steroid prophylaxis. The dose level, gender, race, obesity, or baseline hematologic parameters in peripheral blood did not predict the risk of CRS. Patients with a higher leukemia burden as determined by a higher total WBC, higher percentage of blasts in bone marrow, or higher percentage of blasts in peripheral blood (by hematopathology or immunophenotyping) did not have a higher incidence of CRS. There was an age difference between patients who did versus patients who did not develop CRS (72.9 ± 1.6 years (Median 73.5 years) vs. 63.3 ± 2.3 years (Median: 65.0 years), which was borderline significant (

Indexed as

AMLAPVO436bispecific antibodyCD123clinical studyleukemiaT-cells

Identifiers

PMID34771451
PMCPMC8582601
OpenAlexW3205415604

What OpenQuestion holds

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LicenceCC BY
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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.