Evidence map›Paper›PMID 22684047›Full record

Trial reportBone marrow transplantation2013

The pharmacokinetics and safety of twice daily i.v. BU during conditioning in pediatric allo-SCT recipients.

J B Le Gall, M C Milone, I M Waxman, L M Shaw, L Harrison, D Duffy, C van de Ven, O Militano, M B Geyer, E Morris and 8 more

Abstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Bone marrow transplantation, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 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.

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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Article
  6. New frontiers in pediatric Allo-SCT.Bone marrow transplantation · 2014
    Review
  7. A comparison of bronchoalveolar lavage versus lung biopsy in pediatric recipients after stem cell transplantation.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2014
    Article
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

18 authors.

J B Le GallDepartment of Pediatrics, Columbia University, New York, NY, USA.
M C Milone
I M Waxman
L M Shaw
L Harrison
D Duffy
C van de Ven
O Militano
M B Geyer
E Morris
M Bhatia
P Satwani
D George
J H Garvin
M B Bradley
J Schwartz
L A Baxter-Lowe
M S Cairo

Funding

Nonablative AlloSCT in Refractory Autoimmune DiseaseR21AR049330 · NIAMS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI CAIRO, MITCHELL S. · 2002 to 2003
$164k
NIAMS NIH HHS R21AR49330
6 · The paper itself

Abstract

Intravenous BU divided four times daily (q6 h) has been shown to be safe and effective in pediatric allo-SCT recipients. Though less frequent dosing is desirable, pharmacokinetic (PK) data on twice daily (q12 h) i.v. BU administration in pediatric allo-SCT recipients is limited. We prospectively examined the PK results in a cohort of pediatric allo-SCT recipients receiving i.v. BU q12 h as part of conditioning before allo-SCT. BU levels were obtained after the first dose of conditioning. PK parameter analysis (n=49) yielded the following 95% confidence intervals (CI₉₅): weight-normalized volume of distribution: 0.65-0.73 L/kg; t(1/2): 122-147 min; weight-normalized clearance (CL(n)): 3.4-4.3 mL/min/kg; and area under the curve: 1835-2180 mmol × min/L. From these results, a steady state concentration was calculated with CI₉₅ between 628-746 ng/mL. Comparison between recipients ≤4 vs >4 years old revealed significant differences in t(1/2) (mean: 115 vs 146 min, P=0.008) and CL(n) (mean: 4.4 vs 3.5 mL/min/kg, P=0.038). Intravenous BU q12 h had a comparable PK to i.v. BU q6 h PK seen in the literature, and in pediatric allo-SCT recipients, is a feasible, attractive alternative to i.v. q6h dosing.

Indexed as

AdolescentAge FactorsAntineoplastic Agents, AlkylatingBusulfanChildChild, PreschoolCohort StudiesDrug Administration ScheduleDrug Therapy, CombinationFemaleFollow-Up StudiesGraft SurvivalHalf-LifeHumansInfantInfusions, IntravenousAntineoplastic Agents, AlkylatingBusulfanMyeloablative Agonists

Identifiers

PMID22684047

What OpenQuestion holds

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Registered trials

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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.