Evidence map›Paper›PMID 23907443›Full record

Trial reportCancer chemotherapy and pharmacology2013

A pilot pharmacologic biomarker study in HLA-haploidentical hematopoietic cell transplant recipients.

Meagan J Bemer, Mohamed Sorror, Brenda M Sandmaier, Paul V O'Donnell, Jeannine S McCune

Abstract readClinical Trial
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.6field-weighted citation impact, top 30% 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

8 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Observational
  8. Pharmacokinetic and pharmacodynamic analysis of inosine monophosphate dehydrogenase activity in hematopoietic cell transplantation recipients treated with mycophenolate mofetil.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

5 authors at 2 institutions in 1 country.

Meagan J BemerFred Hutchinson Cancer Research Center, Seattle, WA, USA.
Mohamed Sorror
Brenda M Sandmaier
Paul V O'Donnell
Jeannine S McCune
University of Washington · USFred Hutch Cancer Center · US

Funding

Project 3: Stem Cell Allografts for Lymphoid MalignanciesP01CA078902 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI SANDMAIER, BRENDA MARIE · 1999 to 2025
$46.1M
Population Pharmacokinetics/Pharmacodynamics in Nonablative Stem Cell RecipientsR01HL091744 · NHLBI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI MCCUNE, JEANNINE S · 2008 to 2011
$2.0M
NCI NIH HHS P01 CA078902NHLBI NIH HHS R01 HL091744
6 · The paper itself

Abstract

purposeEleven patients diagnosed with various hematologic malignancies receiving an HLA-haploidentical hematopoietic cell transplant (HCT) participated in an ancillary biomarker trial. The goal of the trial was to evaluate potential pharmacologic biomarkers pertinent to the conditioning regimen [fludarabine monophosphate (fludarabine) and cyclophosphamide (CY)] or postgrafting immunosuppression [CY and mycophenolate mofetil (MMF)] in these patients.

methodsWe characterized the interpatient variability of nine pharmacologic biomarkers. The biomarkers evaluated were relevant to fludarabine (i.e., area under the curve (AUC) of 2-fluoro-ara-A or F-ara-A), CY (i.e., AUCs of CY and four of its metabolites), and MMF (i.e., total mycophenolic acid (MPA) AUC, unbound MPA AUC, and inosine monophosphate dehydrogenase (IMPDH) activity).

resultsInterpatient variability in the pharmacologic biomarkers was high. Among those related to HCT conditioning, the interpatient variability ranged from 1.5-fold (CY AUC) to 4.0-fold (AUC of carboxyethylphosphoramide mustard, a metabolite of CY). Among biomarkers evaluated as part of postgrafting immunosuppression, the interpatient variability ranged from 1.7-fold (CY AUC) to 4.9-fold (IMPDH area under the effect curve). There was a moderate correlation (R (2) = 0.441) of within-patient 4-hydroxycyclophosphamide formation clearance.

conclusionsConsiderable interpatient variability exists in the pharmacokinetic and drug-specific biomarkers potentially relevant to clinical outcomes in HLA-haploidentical HCT recipients. Pharmacodynamic studies are warranted to optimize the conditioning regimen and postgrafting immunosuppression administered to HLA-haploidentical HCT recipients.

Indexed as

AdultAgedArea Under CurveBiomarkers, PharmacologicalCyclophosphamideFemaleHematologic NeoplasmsHematopoietic Stem Cell TransplantationHLA AntigensHumansImmunosuppressive AgentsMaleMiddle AgedMycophenolic AcidPilot ProjectsTransplantation ConditioningBiomarkers, PharmacologicalCyclophosphamidefludarabine phosphateHLA AntigensImmunosuppressive AgentsMycophenolic AcidVidarabine Phosphate

Identifiers

PMID23907443
PMCPMC3786586
OpenAlexW2131814454

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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.