Evidence map›Paper›PMID 19242495›Full record

Trial reportLeukemia2009

Combination of cladribine and cytarabine is effective for childhood acute myeloid leukemia: results of the St Jude AML97 trial.

J E Rubnitz, K R Crews, S Pounds, S Yang, D Campana, V V Gandhi, S C Raimondi, J R Downing, B I Razzouk, C-H Pui and 1 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Leukemia, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05313958 (Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children: A Prospective Multicenter Study in South China), which is not on this map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 8% 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.

NCT05313958 phase2 / phase3unknown statusnot on this mapstarted 2021, after this paper: background citation

Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children: A Prospective Multicenter Study in South China

TypeinterventionalSponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRan2021 to 2026Enrolled43ConditionsLeukemia, Monocytic, Acute, Pediatric AMLArmsCladribine, G-CSF, Cytarabine, Idarubicin, Mitoxantrone
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 63 citations in OpenAlex.

  1. Safety and efficacy of cladribine in multiple sclerosis: a systematic review and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2023
    Pooled it
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  15. Polygenic Ara-C Response Score Identifies Pediatric Patients With Acute Myeloid Leukemia in Need of Chemotherapy Augmentation.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
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  19. Observational
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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

11 authors at 3 institutions in 1 country.

J E RubnitzDepartment of Oncology, St Jude Children's Research Hospital, Memphis, TN 38105-2794, USA. jeffrey.rubnitz@stjude.org
K R Crews
S Pounds
S Yang
D Campana
V V Gandhi
S C Raimondi
J R Downing
B I Razzouk
C-H Pui
R C Ribeiro
St. Jude Children's Research Hospital · USUniversity of Tennessee Health Science Center · USThe University of Texas MD Anderson Cancer Center · US

Funding

Viral Vector Technology (VVTSR)P30CA021765 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI CHARLES ROBERTS · 1985 to 2026
$166.9M
NCI NIH HHS P30 CA021765NCI NIH HHS P30 CA-21765
6 · The paper itself

Abstract

Because cladribine can increase cytarabine triphosphate levels, we tested a cladribine-cytarabine combination in the St Jude AML97, trial in which this combination was administered before standard chemotherapy to 96 children with acute myeloid leukemia (AML) or myelodysplastic syndrome. Patients received a 5-day course of cladribine (9 mg/m(2) per dose) and cytarabine either as daily 2-h infusions (500 mg/m(2) per dose) (arm A) or a continuous infusion (500 mg/m(2) per day) (arm B). Ara-CTP levels and inhibition of DNA synthesis increased from day 1 to day 2, but were not different between the two arms. In addition, the median blast percentages at day 15 did not differ between arms A and B, but patients treated in arm A had shorter intervals between the initiation of the first and second courses of therapy. Thus, although there were trends toward better complete remission rates and overall survival for patients treated in arm B, the reduced efficacy of arm A may have been partially compensated by more intense timing of therapy for that group. For all patients, 5-year event-free survival and overall survival estimates were 44.1+/-5.4 and 50.0+/-5.5%. Our results suggest that cladribine in combination with continuous-infusion cytarabine is effective therapy for childhood AML.

Indexed as

Acute DiseaseAdolescentAntineoplastic Combined Chemotherapy ProtocolsAsparaginaseChildChild, PreschoolCladribineCombined Modality TherapyCytarabineDaunorubicinDown SyndromeDrug Administration ScheduleEtoposideHematopoietic Stem Cell TransplantationHumansInfantAsparaginaseCladribineCytarabineDaunorubicinEtoposide

Identifiers

PMID19242495
PMCPMC2726271
OpenAlexW2045525494

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.