Evidence map›Paper›PMID 30957229›Full record

Trial reportBritish journal of haematology2019

Bortezomib reinduction chemotherapy in high-risk ALL in first relapse: a report from the Children's Oncology Group.

Terzah M Horton, James A Whitlock, Xiaomin Lu, Maureen M O'Brien, Michael J Borowitz, Meenakshi Devidas, Elizabeth A Raetz, Patrick A Brown, William L Carroll, Stephen P Hunger

3 registry-linked trialsOpen access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in British journal of haematology, 2019. 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 61 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 1 pooled it
11.3field-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.

NCT00873093 phase2completednot on this map

A Phase II Pilot Trial of Bortezomib (PS-341, Velcade) in Combination With Intensive Re-Induction Therapy for Children With Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2009 to 2014Enrolled148ConditionsB-cell Adult Acute Lymphoblastic Leukemia, B-cell Childhood Acute Lymphoblastic Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Lymphoblastic LymphomaArmsL-asparaginase, doxorubicin hydrochloride, therapeutic hydrocortisone, vincristine sulfate, cytarabine
NCT05137860 phase4unknown statusnot on this mapstarted 2021, after this paper: background citation

Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive Minimal Residual Disease

TypeinterventionalSponsorHospital General de MexicoRan2021 to 2023Enrolled56ConditionsAcute Lymphoblastic Leukemia, in Relapse, Chemotherapeutic Toxicity, Minimal Residual DiseaseArmsBortezomib
NCT05681260 phase3recruitingnot on this mapstarted 2023, after this paper: background citation

A Randomized Trial Using a Modified COG ABFM Regimen Backbone to Investigate Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL)

TypeinterventionalSponsorChildren's Cancer Group, ChinaRan2023 to 2029Enrolled200ConditionsT-cell Lymphoblastic LymphomaArmsPrednisone,Vincristine, Pegylated-asparaginase, Bortezomib,Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, methotrexate, Dexamethasone, Doxorubicin, Prednisone,Vincristine, Pegylated-asparaginase, Bortezomib,Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, methotrexate, Dexamethasone, Doxorubicin, Vindesine, Etoposide, Ifosfamide
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 1 synthesis or guideline pooled it, 96 citations in OpenAlex.

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

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 8 institutions in 2 countries.

Terzah M HortonTexas Children's Cancer and Hematology Centers at Baylor College of Medicine, Houston, TX, USA.ORCID 0000-0001-8293-4242
James A WhitlockDivision of Pediatric Oncology, Hospital for Sick Children, Toronto, ON, Canada.
Xiaomin LuChildren's Oncology Group - Operations Center, Monrovia, CA, USA.
Maureen M O'BrienCincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Michael J BorowitzJohns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, MD, USA.
Meenakshi DevidasChildren's Oncology Group - Operations Center, Monrovia, CA, USA.
Elizabeth A RaetzDivision of Pediatric Oncology, Primary Children's Hospital, Salt Lake City, UT, USA.
Patrick A BrownJohns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, MD, USA.
William L CarrollDivision of Pediatric Hematology Oncology, Department of Pediatrics, Perlmutter Cancer Center, NYU Langone Medical Center, New York, NY, USA.
Stephen P HungerDepartment of Pediatrics and the Center for Childhood Cancer Research, Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Children's Oncology Group · USJohns Hopkins University · USBaylor College of Medicine · USChildren's Hospital of Philadelphia · USCincinnati Children's Hospital Medical Center · USHospital for Sick Children · CANYU Langone Health · USPrimary Children's Hospital · 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 DEVIDAS, MEENAKSHI · 2003 to 2013
$67.5M
COG U24 Funding 2026-2027U24CA196173 · NCI · RESEARCH INST NATIONWIDE CHILDREN'S HOSP · PI Mignon Lee-Cheun Loh, Nilsa Del Carmen Ramirez Milan · 2015 to 2026
$62.5M
PEDIATRIC ONCOLOGY CLINICAL RESEARCH TRAINING PROGRAMK12CA090433 · NCI · BAYLOR COLLEGE OF MEDICINE · PI CARL E ALLEN, Donald W. Parsons · 2002 to 2026
$18.5M
Improving risk allocation and developing novel therapies for children with T-ALL and T-LLR01CA193776 · NCI · CHILDREN'S HOSP OF PHILADELPHIA · PI Terzah M Horton, ADAM B OLSHEN · 2015 to 2026
$6.2M
Proteosome Inhibition Therapy for Hematologic MalignancyK23CA113775 · NCI · BAYLOR COLLEGE OF MEDICINE · PI HORTON, TERZAH M · 2006 to 2010
$670k
NCI NIH HHS K12 CA090433NCI NIH HHS K23 CA113775NCI NIH HHS R01 CA193776NCI NIH HHS U10 CA098413NCI NIH HHS U10 CA098543NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899NCI NIH HHS U24 CA196173
6 · The paper itself

Abstract

While survival in paediatric acute lymphoblastic leukaemia (ALL) is excellent, survival following relapse is poor. Previous studies suggest proteasome inhibition with chemotherapy improves relapse ALL response rates. This phase 2 Children's Oncology Group study tested the hypothesis that adding the proteasome inhibitor bortezomib to chemotherapy increases complete response rates (CR2). Evaluable patients (n = 135, 103 B-ALL, 22 T-ALL, 10 T-lymphoblastic lymphoma) were treated with reinduction chemotherapy plus bortezomib. Overall CR2 rates were 68 ± 5% for precursor B-ALL patients (<21 years of age), 63 ± 7% for very early relapse (<18 months from diagnosis) and 72 ± 6% for early relapse (18-36 months from diagnosis). Relapsed T-ALL patients had an encouraging CR2 rate of 68 ± 10%. End of induction minimal residual disease (MRD) significantly predicted survival. MRD negative (MRDneg; MRD <0·01%) rates increased from 29% (post-cycle 1) to 64% following cycle 3. Very early relapse, end-of-induction MRDneg precursor B-ALL patients had 70 ± 14% 3-year event-free (EFS) and overall survival (OS) rates, vs. 3-year EFS/OS of 0-3% (P = 0·0001) for MRDpos (MRD ≥0·01) patients. Early relapse patients had similar outcomes (MRDneg 3-year EFS/OS 58-65% vs. MRDpos 10-19%, EFS P = 0·0014). These data suggest that adding bortezomib to chemotherapy in certain ALL subgroups, such as T-cell ALL, is worthy of further investigation. This study is registered at http://www.clinical.trials.gov as NCT00873093.

Indexed as

AdolescentAdultBortezomibChildChild, PreschoolDisease-Free SurvivalFemaleHumansInfantMaleNeoplasm, ResidualPrecursor Cell Lymphoblastic Leukemia-LymphomaRecurrenceSurvival RateTime FactorsBortezomibacute lymphoblastic leukaemiaacute lymphocytic leukaemiaminimal residual diseasepaediatric leukaemiaproteasome inhibition

Identifiers

PMID30957229
PMCPMC6606340
OpenAlexW2936779111

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.