Evidence map›Paper›PMID 25755211›Full record

Trial reportPediatric blood & cancer2015

Safe integration of nelarabine into intensive chemotherapy in newly diagnosed T-cell acute lymphoblastic leukemia: Children's Oncology Group Study AALL0434.

Stuart S Winter, Kimberly P Dunsmore, Meenakshi Devidas, Nancy Eisenberg, Barbara L Asselin, Brent L Wood, Marcia S Leonard Rn, John Murphy, Julie M Gastier-Foster, Andrew J Carroll and 6 more

Abstract readRandomized Controlled Trial
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 43 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 2 pooled it
13.9field-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

43 citing papers in PubMed, 2 syntheses or guidelines pooled it, 85 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Children's Oncology Group AALL0434: A Phase III Randomized Clinical Trial Testing Nelarabine in Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Trial
  6. Successful Outcomes of Newly Diagnosed T Lymphoblastic Lymphoma: Results From Children's Oncology Group AALL0434.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Trial
  7. Trial
  8. Review
  9. Article
  10. Review
  11. The evolution of nutritional care in children and young people with acute lymphoblastic leukaemia: a narrative review.Journal of human nutrition and dietetics : the official journal of the British Dietetic Association · 2025
    Review
  12. Article
  13. Review
  14. Article
  15. Review
  16. Statistical Methods Inspired by Challenges in Pediatric Cancer Multi-omics.Methods in molecular biology (Clifton, N.J.) · 2023
    Article
  17. Article
  18. Article
  19. Advance of structural modification of nucleosides scaffold.European journal of medicinal chemistry · 2021
    Review
  20. 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

16 authors at 15 institutions in 2 countries.

Stuart S WinterUniversity of New Mexico Health Sciences Center, Albuquerque, New Mexico.
Kimberly P DunsmoreUniversity of Virginia Children's Hospital, Charlottesville, Virginia.
Meenakshi DevidasBiostatistics, the University of Florida, Gainesville, Florida.
Nancy EisenbergUniversity of New Mexico Health Sciences Center, Albuquerque, New Mexico.
Barbara L AsselinUniversity of Rochester, Rochester, New York.
Brent L WoodSeattle Children's Hospital, Seattle, Western Australia.
Marcia S Leonard RnC S Mott Children's Hospital, Ann Arbor, Michigan.
John MurphyPrincess Margaret Hospital for Children, Perth, Australia.
Julie M Gastier-FosterNationwide Children's Hospital, Columbus, Ohio.
Andrew J CarrollUniversity of Alabama at Birmingham, Birmingham, Alabama.
Nyla A HeeremaOhio State University, Columbus, Ohio.
Mignon L LohUCSF Medical Center - Parnassus, San Francisco, California.
Elizabeth A RaetzUniversity of Utah, Primary Children's Hospita, Salt Lake City.
Naomi J WinickUniversity of Texas Southwestern Medical Center, Dallas, Texas.
William L CarrollPerlmutter Cancer Center, New York University Langone Medical Center, New York, New York.
Stephen P HungerUniversity of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado.
University of New Mexico · USC. S. Mott Children's Hospital · USNationwide Children's Hospital · USNYU Langone Health · USPrincess Margaret Hospital for Children · AUSeattle Children's Hospital · USThe Ohio State University · USThe University of Texas Southwestern Medical Center · USUniversity of Alabama at Birmingham · USUniversity of California San Francisco Medical Center · USUniversity of Colorado Denver · USUniversity of Florida · USUniversity of Rochester · USUniversity of Utah · USUniversity of Virginia 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
CHILDRENS CANCER STUDY GROUP CHAIRMAN'S GRANTU10CA013539 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI REAMAN, GREGORY H · 1985 to 2002
$43.1M
University of Colorado NTCN Lead Academic Participating Site (LAPS) U10CA180834 · NCI · UNIVERSITY OF COLORADO DENVER · PI ELIAS, ANTHONY D · 2014 to 2018
$3.8M
NCI NIH HHS CA13539NCI NIH HHS CA98543NCI NIH HHS U10 CA098413NCI NIH HHS U10 CA098543NCI NIH HHS U10 CA180834NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899
6 · The paper itself

Abstract

backgroundNelarabine has shown impressive single agent clinical activity in T-cell acute lymphoblastic leukemia (T-ALL), but has been associated with significant neurotoxicities in heavily pre-treated patients. We showed previously that it was safe to add nelarabine to a BFM-86 chemotherapy backbone (AALL00P2). Children's Oncology Group (COG) AALL0434 is a Phase III study designed to test the safety and efficacy of nelarabine when incorporated into a COG augmented BFM-based regimen, which increases exposure to agents with potential neurotoxicity compared to the historical AALL00P2 regimen. PROCEDURE: AALL0434 included a safety phase to assess nelarabine toxicity. Patients with high-risk (HR) T-ALL were randomized to receive Capizzi-style escalating methotrexate (MTX) plus pegaspargase or high dose (HD) MTX with/without six five-days courses of nelarabine. We report results from 94 patients who participated in the initial safety phase of the study.

resultsThere were no differences in the incidence of peripheral motor neuropathies, sensory neuropathies or central neurotoxicities among those randomized to the nelarabine (n = 47) and non-nelarabine arms (n = 47).

conclusionsThe addition of nelarabine to COG-augmented BFM chemotherapy regimen is safe and feasible. The ongoing AALL0434 Efficacy Phase will determine whether the addition of nelarabine treatment improves outcome for patients with T-ALL.

Indexed as

AdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsArabinonucleosidesAsparaginaseChildChild, PreschoolFemaleFollow-Up StudiesHumansInfantMaleMethotrexateNeoplasm StagingPolyethylene GlycolsPrecursor T-Cell Lymphoblastic Leukemia-LymphomaArabinonucleosidesAsparaginaseMethotrexatenelarabinepegaspargasePolyethylene GlycolsBFM chemotherapy regimennelarabineT-ALL

Identifiers

PMID25755211
PMCPMC4433576
OpenAlexW1585375343

What OpenQuestion holds

Textmetadata
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.