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rdf:type |
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lifeskim:mentions |
umls-concept:C0023470,
umls-concept:C0025241,
umls-concept:C0026986,
umls-concept:C0059985,
umls-concept:C0205390,
umls-concept:C1439292,
umls-concept:C1446409,
umls-concept:C1524062,
umls-concept:C1533699,
umls-concept:C1705576,
umls-concept:C2603343
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pubmed:issue |
2
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pubmed:dateCreated |
2008-2-13
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pubmed:abstractText |
We investigated the hypothesis that gemtuzumab ozogamicin (GO), an anti-CD33 immunotoxin would improve the efficacy of fludarabine/melphalan as a preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT) in a phase I/II trial. Toxicity was defined as grades III-IV organ damage, engraftment failure or death within 30 days. 'Response' was engraftment and remission (CR) on day +30. We sought to determine the GO dose (2, 4 or 6 mg m(-2)) giving the best trade-off between toxicity and response. All patients were not candidates for myeloablative regimens. Treatment plan: GO (day -12), fludarabine 30 mg m(-2) (days -5 to -2), melphalan 140 mg m(-2) (day -2) and HSCT (day 0). GVHD prophylaxis was tacrolimus and mini-methotrexate. Diagnoses were AML (n=47), MDS (n=4) or CML (n=1). Median age was 53 years (range, 13-72). All but three patients were not in CR. Donors were related (n=33) or unrelated (n=19). Toxicity and response rates at 4 mg m(-2) were 50% (n=4) and 50% (n=4). GO dose was de-escalated to 2 mg m(-2): 18% had toxicity (n=8) and 82% responded (n=36). 100-day TRM was 15%; one patient had reversible hepatic VOD. Median follow-up was 37 months. Median event-free and overall survival was 6 and 11 months. GO 2 mg m(-2) can be safely added to fludarabine/melphalan, and this regimen merits further evaluation.
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pubmed:language |
eng
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pubmed:journal |
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pubmed:citationSubset |
IM
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pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/Aminoglycosides,
http://linkedlifedata.com/resource/pubmed/chemical/Antibodies, Monoclonal,
http://linkedlifedata.com/resource/pubmed/chemical/Antibodies, Monoclonal, Humanized,
http://linkedlifedata.com/resource/pubmed/chemical/Antigens, CD,
http://linkedlifedata.com/resource/pubmed/chemical/Antigens, Differentiation...,
http://linkedlifedata.com/resource/pubmed/chemical/CD33 antigen,
http://linkedlifedata.com/resource/pubmed/chemical/Melphalan,
http://linkedlifedata.com/resource/pubmed/chemical/Vidarabine,
http://linkedlifedata.com/resource/pubmed/chemical/fludarabine,
http://linkedlifedata.com/resource/pubmed/chemical/gemtuzumab
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pubmed:status |
MEDLINE
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pubmed:month |
Feb
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pubmed:issn |
1476-5551
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pubmed:author |
pubmed-author:AnderliniPP,
pubmed-author:AnderssonB SBS,
pubmed-author:CalderaZZ,
pubmed-author:ChamplinR ERE,
pubmed-author:ChanK WKW,
pubmed-author:CookJ DJD,
pubmed-author:CourielDD,
pubmed-author:GiraltSS,
pubmed-author:HosinoKK,
pubmed-author:JabbourEE,
pubmed-author:KebriaeiPP,
pubmed-author:KhouriII,
pubmed-author:MartinT GTG3rd,
pubmed-author:McCormickGG,
pubmed-author:PatahP APA,
pubmed-author:QazilbashMM,
pubmed-author:ShpallE JEJ,
pubmed-author:ThallP FPF,
pubmed-author:WangXX,
pubmed-author:de LimaMM
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pubmed:issnType |
Electronic
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pubmed:volume |
22
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
258-64
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pubmed:dateRevised |
2011-11-17
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pubmed:meshHeading |
pubmed-meshheading:17989720-Adolescent,
pubmed-meshheading:17989720-Adult,
pubmed-meshheading:17989720-Aged,
pubmed-meshheading:17989720-Aminoglycosides,
pubmed-meshheading:17989720-Antibodies, Monoclonal,
pubmed-meshheading:17989720-Antibodies, Monoclonal, Humanized,
pubmed-meshheading:17989720-Antigens, CD,
pubmed-meshheading:17989720-Antigens, Differentiation, Myelomonocytic,
pubmed-meshheading:17989720-Antineoplastic Combined Chemotherapy Protocols,
pubmed-meshheading:17989720-Disease-Free Survival,
pubmed-meshheading:17989720-Female,
pubmed-meshheading:17989720-Graft Survival,
pubmed-meshheading:17989720-Hematopoietic Stem Cell Transplantation,
pubmed-meshheading:17989720-Humans,
pubmed-meshheading:17989720-Leukemia, Myeloid,
pubmed-meshheading:17989720-Male,
pubmed-meshheading:17989720-Melphalan,
pubmed-meshheading:17989720-Middle Aged,
pubmed-meshheading:17989720-Myelodysplastic Syndromes,
pubmed-meshheading:17989720-Remission Induction,
pubmed-meshheading:17989720-Survival Rate,
pubmed-meshheading:17989720-Transplantation, Homologous,
pubmed-meshheading:17989720-Vidarabine
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pubmed:year |
2008
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pubmed:articleTitle |
Phase I/II study of gemtuzumab ozogamicin added to fludarabine, melphalan and allogeneic hematopoietic stem cell transplantation for high-risk CD33 positive myeloid leukemias and myelodysplastic syndrome.
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pubmed:affiliation |
Department of Stem Cell Transplantation and Cell Therapy, U.T.M.D. Anderson Cancer Center, Houston, TX 77030-4009, USA. mdelima@mdanderson.org
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pubmed:publicationType |
Journal Article,
Clinical Trial, Phase II,
Clinical Trial, Phase I
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