Evidence map›Paper›PMID 19553647›Full record

Trial reportThe New England journal of medicine2009

Treating childhood acute lymphoblastic leukemia without cranial irradiation.

Ching-Hon Pui, Dario Campana, Deqing Pei, W Paul Bowman, John T Sandlund, Sue C Kaste, Raul C Ribeiro, Jeffrey E Rubnitz, Susana C Raimondi, Mihaela Onciu and 14 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 574 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
574citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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.

NCT00137111 phase3completednot on this map

Total XV - Total Therapy Study XV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia

TypeinterventionalSponsorSt. Jude Children's Research HospitalRan2000 to 2014Enrolled501ConditionsLymphoblastic Leukemia, AcuteArmsPrednisone, Dexamethasone, Vincristine, Daunorubicin, Doxorubicin, L-asparaginase, PEG-L-asparaginase, Erwinia asparaginase, Methotrexate, Cyclophosphamide, Cytarabine, Etoposide, Mercaptopurine, Imatinib, chemotherapy, intrathecal chemotherapy
NCT06560879 phase2enrolling by invitationnot on this mapstarted 2025, after this paper: background citation

Effectiveness of Probiotics for the Prevention of Gastrointestinal Toxicity and Changes in Gut Microbiota in Children With Acute Lymphoblastic Leukemia

TypeinterventionalSponsorNational Institute of Pediatrics, MexicoRan2025 to 2026Enrolled120ConditionsProbiotics, Gastrointestinal Diseases, Precursor Cell Lymphoblastic Leukemia-LymphomaArmsLactobacillus casei, Lactobacillus rhamnosus, Bifidobacterium bifidum, Placebo
3 · Its place in the literature

Who cites it

574 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors.

Ching-Hon PuiDepartment of Oncology, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. ching-hon.pui@stjude.org
Dario Campana
Deqing Pei
W Paul Bowman
John T Sandlund
Sue C Kaste
Raul C Ribeiro
Jeffrey E Rubnitz
Susana C Raimondi
Mihaela Onciu
Elaine Coustan-Smith
Larry E Kun
Sima Jeha
Cheng Cheng
Scott C Howard
Vickey Simmons
Amy Bayles
Monika L Metzger
James M Boyett
Wing Leung
Rupert Handgretinger
James R Downing
William E Evans
Mary V Relling

Funding

Viral Vector Technology (VVTSR)P30CA021765 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI CHARLES ROBERTS · 1985 to 2026
$166.9M
Whole GenomeU01GM061393 · NIGMS · UNIVERSITY OF CHICAGO · PI DOLAN, MARY EILEEN · 2000 to 2014
$39.0M
PHARMACOGENOMICS OF CHILDHOOD LEUKEMIA (ALL)R37CA036401 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI EVANS, WILLIAM E · 1987 to 2014
$9.7M
Pharmacogenomics of Childhood Leukemia ALLR01CA036401 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI EVANS, WILLIAM E · 1985 to 2019
$3.6M
PHARMACODYNAMICS OF ANTILEUKEMIC AGENTS IN CHILDRENR01CA078224 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI SPARREBOOM, ALEXANDER · 1998 to 2007
$3.6M
P450 METABOLISM OF EPIPODOPHYLLOTOXINS IN CHILDRENR01CA051001 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI RELLING, MARY V. · 1996 to 2006
$2.7M
DETECTION AND THERAPY OF RESIDUAL LEUKEMIA IN CHILDRENR01CA060419 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI CAMPANA, DARIO · 1998 to 2006
$1.7M
POLYMORPHIC METABOLISM OF ANTINEOPLASTICS IN CHILDRENR29CA051001 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI RELLING, MARY V. · 1990 to 1994
–
DETECTION OF MINIMAL RESIDUAL LEUKEMIA IN CHILDRENU01CA060419 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI CAMPANA, DARIO · 1993 to 1996
–
NCI NIH HHS CA21765NCI NIH HHS CA36401NCI NIH HHS CA51001NCI NIH HHS CA60419NCI NIH HHS CA78224NCI NIH HHS P30 CA021765NCI NIH HHS R01 CA036401NCI NIH HHS R01 CA051001NCI NIH HHS R01 CA060419NCI NIH HHS R01 CA078224NCI NIH HHS R37 CA036401NCI NIH HHS U01 CA060419NIGMS NIH HHS GM61393NIGMS NIH HHS U01 GM061393
6 · The paper itself

Abstract

backgroundProphylactic cranial irradiation has been a standard treatment in children with acute lymphoblastic leukemia (ALL) who are at high risk for central nervous system (CNS) relapse.

methodsWe conducted a clinical trial to test whether prophylactic cranial irradiation could be omitted from treatment in all children with newly diagnosed ALL. A total of 498 patients who could be evaluated were enrolled. Treatment intensity was based on presenting features and the level of minimal residual disease after remission-induction treatment. The duration of continuous complete remission in the 71 patients who previously would have received prophylactic cranial irradiation was compared with that of 56 historical controls who received it.

resultsThe 5-year event-free and overall survival probabilities for all 498 patients were 85.6% (95% confidence interval [CI], 79.9 to 91.3) and 93.5% (95% CI, 89.8 to 97.2), respectively. The 5-year cumulative risk of isolated CNS relapse was 2.7% (95% CI, 1.1 to 4.3), and that of any CNS relapse (including isolated relapse and combined relapse) was 3.9% (95% CI, 1.9 to 5.9). The 71 patients had significantly longer continuous complete remission than the 56 historical controls (P=0.04). All 11 patients with isolated CNS relapse remained in second remission for 0.4 to 5.5 years. CNS leukemia (CNS-3 status) or a traumatic lumbar puncture with blast cells at diagnosis and a high level of minimal residual disease (> or = 1%) after 6 weeks of remission induction were significantly associated with poorer event-free survival. Risk factors for CNS relapse included the genetic abnormality t(1;19)(TCF3-PBX1), any CNS involvement at diagnosis, and T-cell immunophenotype. Common adverse effects included allergic reactions to asparaginase, osteonecrosis, thrombosis, and disseminated fungal infection.

conclusionsWith effective risk-adjusted chemotherapy, prophylactic cranial irradiation can be safely omitted from the treatment of childhood ALL. (ClinicalTrials.gov number, NCT00137111.)

Indexed as

AdolescentAntineoplastic Combined Chemotherapy ProtocolsAsparaginaseCentral Nervous System NeoplasmsChildChild, PreschoolCombined Modality TherapyCranial IrradiationCyclophosphamideDaunorubicinDexamethasoneHematopoietic Stem Cell TransplantationHumansInfantMercaptopurineMethotrexateAsparaginaseCyclophosphamideDaunorubicinDexamethasoneMercaptopurineMethotrexateVincristine

Identifiers

PMID19553647
PMCPMC2754320

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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.