Evidence map›Paper›PMID 26261894›Full record

Trial reportJournal of immunotherapy (Hagerstown, Md. : 1997)2015

Feasibility Study of a Novel Experimental Induction Protocol Combining B43-PAP (Anti-CD19) Immunotoxin With Standard Induction Chemotherapy in Children and Adolescents With Relapsed B-Lineage ALL: A Report From the Children's Oncology Group.

Holly J Meany, Nita L Seibel, Mark Krailo, Doojduen Villaluna, Zhengjia Chen, Paul Gaynon, Joseph P Neglia, Julie R Park, Raymond Hutchinson, Judith K Sato and 3 more

Open access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Journal of immunotherapy (Hagerstown, Md. : 1997), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.9field-weighted citation impact, top 23% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
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 8 institutions in 2 countries.

Holly J Meany*Department of Pediatric Hematology-Oncology, Children's National Medical Center, George Washington University School of Medicine and Public Health, Washington, DC †Clinical Investigations Branch, Cancer Therapy Evaluation Program, NCI, Bethesda ¶¶Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD ‡Keck School of Medicine, University of Southern California ¶Division of Hematology-Oncology, Children's Hospital Los Angeles, Los Angeles §Children's Oncology Group, Arcadia ‡‡Department of Pediatrics, City of Hope National Medical Center, Duarte, CA ∥Department of Biostatistics and Bioinformatics, Emory University ∥∥Aflac Cancer and Blood Disorder Center, Children's Healthcare of Atlanta/Emory University, Atlanta, GA #Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN **Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle, WA ††Pediatric Hematology-Oncology, C.S. Mott Children's Hospital, Ann Arbor, MI §§Division of Pediatrics, Children's Cancer Hospital at the University of Texas M.D. Anderson Cancer Center, Houston, TX.
Nita L Seibel
Mark Krailo
Doojduen Villaluna
Zhengjia Chen
Paul Gaynon
Joseph P Neglia
Julie R Park
Raymond Hutchinson
Judith K Sato
Robert J Wells
William G Woods
Gregory Reaman
Arcadia · USCenter for Cancer Research · USChildren's Hospital of Los Angeles · USEmory University · USUniversity of Southern California · USChildren's National · USChildren's Oncology Group · CHUniversity of Minnesota Medical Center · US

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
COG FOREIGN ACCRUALU10CA098543 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI ADAMSON, PETER C. · 2003 to 2013
$335.5M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
Children's Oncology Group Statistics &Data Center GrantU10CA098413 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI ANDERSON, JAMES R · 2003 to 2013
$67.5M
NCI NIH HHS CA180886NCI NIH HHS CA180899NCI NIH HHS CA98413NCI NIH HHS CA98543NCI NIH HHS U10 CA098413NCI NIH HHS U10 CA098543NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899
6 · The paper itself

Abstract

backgroundB43-pokeweed antiviral protein (B43-PAP) is a high-affinity anti-CD19 immunotoxin that is capable of causing apoptotic death in B-lineage leukemic cells with a drug-resistant phenotype. B43-PAP exhibited in vivo antileukemic activity in preclinical studies as well as on a single-agent phase I clinical trial. This pediatric phase I/II study evaluated the toxicity profile and efficacy of B43-PAP immunotoxin in combination with standard induction chemotherapy in children and adolescents with relapsed CD19-positive B-lineage acute lymphoblastic leukemia (B-ALL). Pharmacokinetic profile and immunogenicity of B43-PAP were assessed. EXPERIMENTAL

designB43-PAP in combination with standard 3 and 4-drug induction chemotherapy was administered on days 9-13 and 21-25 of a 28-day treatment course with vincristine, prednisone, L-asparaginase, daunomycin, and intrathecal methotrexate. Thirty patients with relapsed B-ALL were enrolled on study CCG-0957.

resultsGrade III/IV nonhematologic dose-limiting toxicities were encountered in 4 patients evaluable for toxicity and included myalgias, motor dysfunction, pulmonary toxicity, and elevated liver transaminase. Dose-limiting toxicities occurred only with the 4-drug regimen. Fourteen patients achieved a complete remission at the end of induction among the 20 patients evaluable for response.

conclusionsB43-PAP in combination with standard induction chemotherapy can be safely administered and exhibits clinical antileukemic activity against relapsed B-ALL.

Indexed as

AdolescentAntibodies, MonoclonalAntigens, CD19Antineoplastic AgentsB-LymphocytesChildChild, PreschoolDrug Therapy, CombinationFeasibility StudiesFemaleHumansImmunotoxinsInduction ChemotherapyMalePrecursor Cell Lymphoblastic Leukemia-LymphomaRibosome Inactivating Proteins, Type 1Antibodies, MonoclonalAntigens, CD19Antineoplastic AgentsImmunotoxinspokeweed antiviral proteinRibosome Inactivating Proteins, Type 1

Identifiers

PMID26261894
PMCPMC4536569
OpenAlexW2253263017

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

Registered trials

None linked

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.