Evidence map›Paper›PMID 31969338›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2020

Decitabine and Vorinostat with Chemotherapy in Relapsed Pediatric Acute Lymphoblastic Leukemia: A TACL Pilot Study.

Michael J Burke, Rumen Kostadinov, Richard Sposto, Lia Gore, Shannon M Kelley, Cara Rabik, Jane B Trepel, Min-Jung Lee, Akira Yuno, Sunmin Lee and 24 more

Registry-linked trialOpen access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01483690 (A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL), which is not on this map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
5.6field-weighted citation impact, top 3% 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.

NCT01483690 phase1 / phase2terminatednot on this map

A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL

TypeinterventionalSponsorTherapeutic Advances in Childhood Leukemia ConsortiumRan2011 to 2015Enrolled23ConditionsAcute Lymphoblastic Leukemia, Precursor B-Cell Lymphoblastic Leukemia, Precursor T-Cell Lymphoblastic LeukemiaArmsDecitabine, Vorinostat, Vincristine, Dexamethasone, Mitoxantrone
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 42 citations in OpenAlex.

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  19. Frontiers in oncology · 2022
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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

34 authors at 19 institutions in 2 countries.

Michael J Burke *Division of Pediatric Hematology-Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin. mmburke@mcw.edu.
Rumen Kostadinov *Division of Pediatric Oncology, Johns Hopkins University, Baltimore, Maryland.ORCID 0000-0002-8617-2836
Richard SpostoChildren's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, USC Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, California.
Lia GoreChildren's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado.
Shannon M KelleyDivision of Pediatric Oncology, Johns Hopkins University, Baltimore, Maryland.
Cara RabikDivision of Pediatric Oncology, Johns Hopkins University, Baltimore, Maryland.
Jane B TrepelNCI, NIH, Bethesda, Maryland.
Min-Jung LeeNCI, NIH, Bethesda, Maryland.ORCID 0000-0001-6011-151X
Akira YunoNCI, NIH, Bethesda, Maryland.
Sunmin LeeNCI, NIH, Bethesda, Maryland.ORCID 0000-0001-6011-151X
Deepa BhojwaniChildren's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, USC Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, California.
Sima JehaSt. Jude Children's Research Hospital, Memphis, Tennessee.
Bill H ChangDepartment of Pediatrics, Oregon Health and Science University, Portland, Oregon.ORCID 0000-0003-3783-1820
Maria Luisa SulisDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, New York.
Michelle L HermistonDepartment of Pediatrics, UCSF Medical Center-Mission Bay, San Francisco, California.
Paul GaynonDivision of Pediatric Oncology, Johns Hopkins University, Baltimore, Maryland.
Van HuynhDepartment of Pediatrics, Children's Hospital of Orange County, Orange, California.
Anupam VermaDepartment of Pediatrics, Primary Children's Hospital, University of Utah, Salt Lake City, Utah.ORCID 0000-0001-6555-7924
Rebecca GardnerDepartment of Pediatrics, Seattle Children's Hospital, Seattle, Washington.
Kenneth M HeymDepartment of Pediatrics, Cook Children's Medical Center, Fort Worth, Texas.
Robyn M DennisDepartment of Pediatrics, Nationwide Children's Hospital, Columbus, Ohio.
David S ZieglerKids Cancer Centre, Sydney Children's Hospital, Randwick, Australia.
Theodore W LaetschDepartment of Pediatrics, UT Southwestern/Harold C. Simmons Comprehensive Cancer Center, Dallas, Texas.ORCID 0000-0002-8497-3138
Javier E OesterheldDepartment of Pediatrics, Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina.
Steven G DuboisDepartment of Pediatrics, Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, Massachusetts.
Jessica A PollardDepartment of Pediatrics, Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, Massachusetts.
Julia Glade-BenderDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, New York.
Todd M CooperDepartment of Pediatrics, Seattle Children's Hospital, Seattle, Washington.
Joel A KaplanDepartment of Pediatrics, Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina.
Midhat S FarooqiCenter for Pediatric Genomic Medicine, Children's Mercy Hospital, Kansas City, Missouri.ORCID 0000-0002-5238-1349
Byunggil YooCenter for Pediatric Genomic Medicine, Children's Mercy Hospital, Kansas City, Missouri.
Erin GuestCenter for Pediatric Genomic Medicine, Children's Mercy Hospital, Kansas City, Missouri.ORCID 0000-0003-2482-5608
Alan S WayneDivision of Pediatric Oncology, Johns Hopkins University, Baltimore, Maryland.
Patrick A BrownDivision of Pediatric Oncology, Johns Hopkins University, Baltimore, Maryland.
Johns Hopkins University · USNational Institutes of Health · USUniversity of Southern California · USChildren's Mercy Hospital · USCarolinas Medical Center · USDana-Farber/Boston Children's Cancer and Blood Disorders Center · USMemorial Sloan Kettering Cancer Center · USSeattle Children's Hospital · USChildren's Hospital of Orange County · USCook Children's Medical Center · USMedical College of Wisconsin · USNationwide Children's Hospital · USOregon Health & Science University · USPrimary Children's Hospital · USSouthwestern Medical Center · USSt. Jude Children's Research Hospital · USSydney Children's Hospital · AUUniversity of California San Francisco Medical Center · USUniversity of Colorado Hospital · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
USC/NORRIS COMPREHENSIVE CANCER CENTER (CORE) SUPPORTP30CA014089 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI MYLES G COCKBURN · 1985 to 2026
$181.4M
Southern California Clinical and Translational Science InstituteUL1TR001855 · NCATS · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Thomas A Buchanan, Michele D. Kipke · 2016 to 2026
$81.3M
Signal Transduction Events and the Regulation of Cell GrowthZICSC006743 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI TREPEL, JANE B · 2009 to 2023
$13.8M
A Pilot Study of Decitabine and Vorinostat with Chemotherapy for Relapsed ALLR21CA161688 · NCI · UNIVERSITY OF MINNESOTA · PI BROWN, PATRICK A, BURKE, MICHAEL JAMES · 2011 to 2012
$682k
NCATS NIH HHS UL1 TR001855NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA014089NCI NIH HHS R21 CA161688
6 · The paper itself

Abstract

purposeTreatment failure from drug resistance is the primary reason for relapse in acute lymphoblastic leukemia (ALL). Improving outcomes by targeting mechanisms of drug resistance is a potential solution. PATIENTS AND

methodsWe report results investigating the epigenetic modulators decitabine and vorinostat with vincristine, dexamethasone, mitoxantrone, and PEG-asparaginase for pediatric patients with relapsed or refractory B-cell ALL (B-ALL). Twenty-three patients, median age 12 years (range, 1-21) were treated in this trial.

resultsThe most common grade 3-4 toxicities included hypokalemia (65%), anemia (78%), febrile neutropenia (57%), hypophosphatemia (43%), leukopenia (61%), hyperbilirubinemia (39%), thrombocytopenia (87%), neutropenia (91%), and hypocalcemia (39%). Three subjects experienced dose-limiting toxicities, which included cholestasis, steatosis, and hyperbilirubinemia (

conclusionsDespite encouraging response rates and pharmacodynamics, the combination of decitabine and vorinostat on this intensive chemotherapy backbone was determined not feasible in B-ALL due to the high incidence of significant infectious toxicities. This study is registered at http://www.clinicaltrials.gov as NCT01483690.

Indexed as

AdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsAsparaginaseBortezomibChildChild, PreschoolDecitabineDexamethasoneDoxorubicinFemaleFollow-Up StudiesHumansInfantMaleMitoxantroneAsparaginaseBortezomibDecitabineDexamethasoneDoxorubicinMitoxantronepegaspargasePolyethylene GlycolsVincristineVorinostat

Identifiers

PMID31969338
PMCPMC7477726
OpenAlexW3002371950

What OpenQuestion holds

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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.