Evidence map›Paper›PMID 21352197›Full record

Trial reportBritish journal of haematology2011

A pilot study evaluating the safety and CD34+ cell mobilizing activity of escalating doses of plerixafor in healthy volunteers.

Steven J Lemery, Matthew M Hsieh, Aleah Smith, Sheila Rao, Hanh M Khuu, Donohue Theresa, Jennifer M Viano, Lisa Cook, Rose Goodwin, Carol Boss and 4 more

Open access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in British journal of haematology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.2field-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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. 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

14 authors at 1 institution in 1 country.

Steven J LemeryNHLBI, NIH, Bethesda, MD, USA.
Matthew M Hsieh
Aleah Smith
Sheila Rao
Hanh M Khuu
Donohue Theresa
Jennifer M Viano
Lisa Cook
Rose Goodwin
Carol Boss
Gary Calandra
Nancy Geller
John Tisdale
Richard Childs
National Institutes of Health · US

Funding

Allogeneic Immunotherapy for cancer and nonmalignant hematological disordersZIAHL002345 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI CHILDS, RICHARD · 2009 to 2025
$53.3M
Isolation, characterization, and transplantation of candidate stem cellsZIAHL006009 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI TISDALE, JOHN · 2009 to 2025
$13.5M
Intramural NIH HHS Z99 HL999999
6 · The paper itself

Abstract

This study evaluated the safety and CD34+ cell mobilizing activity of escalating doses of plerixafor in healthy volunteers. Three cohorts of six subjects received two different doses of plerixafor separated by at least 2 weeks to allow for adequate pharmacodynamic wash-out. The following dosing cohorts were evaluated: 0·24 and 0·32 mg/kg (Cohort 1); 0·32 and 0·40 mg/kg (Cohort 2); and 0·40 and 0·48 mg/kg (Cohort 3). Circulating CD34+ cells were measured 0, 2, 4, 6, 8, 10, 12, 14, 18 and 24 h after each dose. Blood colony-forming units were measured at baseline and 6 h after each dose. Common adverse events were diarrhoea, injection site erythema, perioral numbness, sinus tachycardia, headache, nausea, abdominal distention and injection site pain. No dose limiting toxicities occurred. When higher doses of plerixafor were administered, there was a trend towards higher peak CD34+ counts and CD34+ area under the curves, although these differences did not achieve statistical significance, perhaps due to intra-subject variability. Together, these data show that the higher doses of plerixafor evaluated in this study are reasonably safe and suggest that a larger study should be performed to definitively answer whether increased numbers of CD34+ cell are mobilized with higher doses of plerixafor.

Indexed as

AdolescentAdultAntigens, CD34BenzylaminesCohort StudiesColony-Forming Units AssayCyclamsDose-Response Relationship, DrugFemaleHematopoietic Stem Cell MobilizationHeterocyclic CompoundsHumansMaleMiddle AgedPilot ProjectsReceptors, CXCR4Antigens, CD34BenzylaminesCyclamsHeterocyclic CompoundsplerixaforReceptors, CXCR4

Identifiers

PMID21352197
PMCPMC3879799
OpenAlexW1816641574

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.