Document Detail


Direct intrabone transplant of unrelated cord-blood cells in acute leukaemia: a phase I/II study.
MedLine Citation:
PMID:  18693069     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Cord-blood transplants are associated with delayed or failed engraftment in about 20% of adult patients. The aim of this phase I/II study was to establish the safety and efficacy of a new administration route (intrabone) for cord-blood cells, measured by the donor-derived neutrophil and platelet engraftment.
METHODS: Adult patients with acute leukaemia, for whom an unrelated stem-cell transplantation was indicated and no suitable unrelated human leucocyte antigen (HLA)-matched donor had been identified, were included in the study and underwent a cord-blood transplant in San Martino Hospital, Genoa, Italy. Eight patients were in first complete remission, ten in second complete remission, and 14 had advanced-stage, refractory disease. HLA matching was 5/6, 4/6, and 3/6 for 9, 22, and one patient, respectively. Cord-blood cells were concentrated in four 5-mL syringes, and were infused in the superior-posterior iliac crest under rapid general anaesthesia. Median transplanted cell dose was 2.6 x 10(7)/kg (range 1.4-4.2). The primary endpoint was the probability of neutrophil and platelet recovery after intrabone cord-blood transplantantion. Secondary endpoints included the incidence of acute graft-versus-host disease, relapse, and overall survival. This trial is registered on the ClinicalTrials.gov website, number NCT 00696046.
FINDINGS: Between March 31, 2006, and Jan 25, 2008, 32 consecutive patients with acute myeloid leukaemia (n=20) or acute lymphoblastic leukaemia (n=12) underwent a cord-blood transplant (median age 36 years [range 18-66]). No complications occurred during or after the intrabone infusion of cells. Four patients with advanced-stage disease died within 12 days of the procedure. Median time to recovery of neutrophils in 28 patients (>/=0.5 x 10(9)/L) was 23 days (range 14-44) and median time to recovery of platelets in 27 patients (>/=20 x 10(9)/L) was 36 days (range 16-64). All patients were fully chimeric from 30 days after transplantation to the last follow-up visit, suggesting an early complete donor engraftment. No patient developed grade III-IV acute graft-versus-host disease. Causes of death were transplant related (n=5), infection (n=7), and relapse (n=4). 16 patients were alive and in haematological remission at a median follow-up of 13 months (range 3-23).
INTERPRETATION: Our preliminary data suggest that direct intrabone cord-blood transplantation overcomes the problem of graft failure even when low numbers of HLA-mismatched cord-blood cells are transplanted, thus leading to the possibility of use of this technique in a large number of adult patients.
Authors:
Francesco Frassoni; Francesca Gualandi; Marina Podestà; Anna Maria Raiola; Adalberto Ibatici; Giovanna Piaggio; Mario Sessarego; Nadia Sessarego; Marco Gobbi; Nicoletta Sacchi; Myriam Labopin; Andrea Bacigalupo
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Publication Detail:
Type:  Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't     Date:  2008-08-08
Journal Detail:
Title:  The Lancet. Oncology     Volume:  9     ISSN:  1474-5488     ISO Abbreviation:  Lancet Oncol.     Publication Date:  2008 Sep 
Date Detail:
Created Date:  2008-09-01     Completed Date:  2008-09-16     Revised Date:  2014-08-18    
Medline Journal Info:
Nlm Unique ID:  100957246     Medline TA:  Lancet Oncol     Country:  England    
Other Details:
Languages:  eng     Pagination:  831-9     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00696046
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Cord Blood Stem Cell Transplantation / methods*
Humans
Infusions, Intraosseous
Leukemia, Myeloid, Acute / therapy*
Middle Aged
Precursor Cell Lymphoblastic Leukemia-Lymphoma / therapy*
Transplantation, Homologous
Treatment Outcome
Comments/Corrections
Comment In:
Lancet Oncol. 2008 Sep;9(9):812-4   [PMID:  18760236 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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