Evidence map›Paper›PMID 33037919›Full record

Trial reportCancer chemotherapy and pharmacology2020

Pharmacokinetics of alemtuzumab in pediatric patients undergoing ex vivo T-cell-depleted haploidentical hematopoietic cell transplantation.

Senthil Velan Bhoopalan, Shane J Cross, John C Panetta, Brandon M Triplett

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 23% 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

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
  5. 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

4 authors at 1 institution in 1 country.

Senthil Velan BhoopalanDepartment of Hematology, St. Jude Children's Research Hospital, Memphis, TN, 38105, USA.ORCID 0000-0002-1402-6549
Shane J CrossDepartment of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, TN, 38105, USA.
John C PanettaDepartment of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, TN, 38105, USA.
Brandon M TriplettDepartment of Bone Marrow Transplantation and Cell Therapy, St. Jude Children's Research Hospital, MS 1130, Room I3305, 262 Danny Thomas Place, Memphis, TN, 38105, USA. brandon.triplett@stjude.org.
St. Jude Children's Research Hospital · 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 CA021765
6 · The paper itself

Abstract

purposeAlemtuzumab is a humanized monoclonal antibody against CD52 which is predominantly present on T and B lymphocytes. Alemtuzumab has been used as part of conditioning regimens for prophylaxis against rejection and GVHD. While the mechanism of action is well understood, the pharmacokinetics of this drug in children needed to be studied in more detail especially in the setting of ex vivo T-cell-depleted hematopoietic cell transplantation (HCT).

methodsSerum alemtuzumab levels were measured at various time points in 13 patients who underwent haploidentical HCT utilizing ex vivo donor T-cell depletion. Alemtuzumab was administered subcutaneously at a cumulative dose of 45 mg/m

resultsWe determined the median half-life to be 11 days. Alemtuzumab clearance increased with increasing baseline lymphocyte count (p = 0.008). Additionally, clearance increased with weight and age (p ≤ 0.035). AUC of alemtuzumab did not have any significant relationship with type of leukemia, overall survival, engraftment, immune reconstitution, mixed chimerism or GVHD, although the number of subjects in this pilot study was limited.

conclusionAbsolute lymphocyte count and body weight affect alemtuzumab clearance. We also demonstrate feasibility of body-surface area-based dosing of alemtuzumab in pediatric HCT patients. Further studies are needed to evaluate the role of monitoring alemtuzumab serum concentrations to balance the prevention of graft rejection and GVHD with the promotion of rapid donor immune reconstitution.

Indexed as

AdolescentAlemtuzumabBody Surface AreaChildChild, PreschoolDrug Dosage CalculationsDrug MonitoringFeasibility StudiesFemaleFollow-Up StudiesGraft RejectionGraft vs Host DiseaseHalf-LifeHematopoietic Stem Cell TransplantationHumansInjections, SubcutaneousAlemtuzumabAlemtuzumabBone marrowCampathHaploidentical bone marrow transplantationPediatric bone marrow transplantationPeripheral blood stem cellPharmacokineticsT-cell-depleted transplantation

Identifiers

PMID33037919
PMCPMC7735192
OpenAlexW3091860014

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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.