Evidence map›Paper›PMID 25732247›Full record

Trial reportPediatric blood & cancer2015

Re-induction chemoimmunotherapy with epratuzumab in relapsed acute lymphoblastic leukemia (ALL): Phase II results from Children's Oncology Group (COG) study ADVL04P2.

Elizabeth A Raetz, Mitchell S Cairo, Michael J Borowitz, Xiaomin Lu, Meenakshi Devidas, Joel M Reid, David M Goldenberg, William A Wegener, Hui Zeng, James A Whitlock and 3 more

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

Trial report in Pediatric blood & cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 2 pooled it
13.6field-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.

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

58 citing papers in PubMed, 2 syntheses or guidelines pooled it, 98 citations in OpenAlex.

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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 9 institutions in 2 countries.

Elizabeth A RaetzDepartment of Pediatrics and Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah.
Mitchell S CairoDepartment of Pediatrics, New York Medical College, New York, New York.
Michael J BorowitzDepartment of Pathology, Johns Hopkins University, Baltimore, Maryland.
Xiaomin LuDepartment of Biostatistics, Colleges of Medicine, Public Health & Health Professions, University of Florida, Gainesville, Florida.
Meenakshi DevidasDepartment of Biostatistics, Colleges of Medicine, Public Health & Health Professions, University of Florida, Gainesville, Florida.
Joel M ReidDepartment of Oncology, Mayo Clinic, Rochester, Minnesota.
David M GoldenbergImmunomedics, Inc., Morris Plains, New Jersey.
William A WegenerImmunomedics, Inc., Morris Plains, New Jersey.
Hui ZengDepartment of Biostatistics, Colleges of Medicine, Public Health & Health Professions, University of Florida, Gainesville, Florida.
James A WhitlockDepartment of Pediatrics, University of Toronto and the Hospital for Sick Children, Toronto, Ontario.
Peter C AdamsonDepartment of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Stephen P HungerDepartment of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
William L CarrollNYU Perlmutter Cancer Center and Department of Pediatrics, NYU Langone Medical Center, New York, New York.
University of Florida · USChildren's Hospital of Philadelphia · USImmunomedics (United States) · USHospital for Sick Children · CAJohns Hopkins University · USMayo Clinic · USNew York Medical College · USNYU Langone Health · USUniversity of Utah · 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 U10 CA098413NCI NIH HHS U10 CA098543NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899NCI NIH HHS U10 CA98413NCI NIH HHS U10CA98543
6 · The paper itself

Abstract

backgroundGiven the success of immunotherapeutic approaches in hematologic malignancies, the COG designed a phase I/II study to determine whether the addition of epratuzumab (anti-CD22) to an established chemotherapy platform improves rates of second remission (CR2) in pediatric patients with B-lymphoblastic leukemia (B-ALL) and early bone marrow relapse. PROCEDURE: Therapy consisted of three established blocks of re-induction chemotherapy. Epratuzumab (360 mg/m(2)/dose) was combined with chemotherapy on weekly × 4 (B1) and twice weekly × 4 [eight doses] (B2) schedules during the first re-induction block. Remission rates and minimal residual disease (MRD) status were compared to historical rates observed with the identical chemotherapy platform alone.

resultsCR2 was achieved in 65 and 66%, of the evaluable B1 (n = 54) and B2 patients (n = 60), respectively; unchanged from that observed historically without epratuzumab. Rates of MRD negativity (<0.01%) were 31% in B1 (P = 0.4128) and 39% in B2 patients (P = 0.1731), compared to 25% in historical controls. The addition of epratuzumab was well tolerated, with a similar toxicity profile to that observed with the re-induction chemotherapy platform regimen alone.

conclusionsEpratuzumab was well tolerated in combination with re-induction chemotherapy. While CR2 rates were not improved compared to historical controls treated with chemotherapy alone, there was a non-significant trend towards improvement in MRD response with the addition of epratuzumab (twice weekly for eight doses) to re-induction chemotherapy.

Indexed as

ImmunotherapyAdolescentAdultAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsChildChild, PreschoolCohort StudiesCombined Modality TherapyFemaleFollow-Up StudiesHumansInfantMaleNeoplasm Recurrence, LocalNeoplasm StagingAntibodies, Monoclonal, Humanizedepratuzumabepratuzumabmonoclonal antibodyrelapsed ALL

Identifiers

PMID25732247
PMCPMC4701208
OpenAlexW2159877301

What OpenQuestion holds

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Registered trials

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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.