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01000naa a22002652 4500 |
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NLM113677936 |
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DE-627 |
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20231222164331.0 |
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231222s2001 xx ||||| 00| ||eng c |
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|a pubmed24n0379.xml
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|a (DE-627)NLM113677936
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|a (NLM)11465948
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|a DE-627
|b ger
|c DE-627
|e rakwb
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| 041 |
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|a eng
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| 100 |
1 |
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|a Hall, P D
|e verfasserin
|4 aut
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| 245 |
1 |
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|a Antibody response to DT-GM, a novel fusion toxin consisting of a truncated diphtheria toxin (DT) linked to human granulocyte-macrophage colony stimulating factor (GM), during a phase I trial of patients with relapsed or refractory acute myeloid leukemia
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| 264 |
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|c 2001
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| 336 |
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|a Text
|b txt
|2 rdacontent
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| 337 |
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|a ohne Hilfsmittel zu benutzen
|b n
|2 rdamedia
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| 338 |
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|a Band
|b nc
|2 rdacarrier
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| 500 |
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|a Date Completed 23.08.2001
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| 500 |
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|a Date Revised 14.11.2007
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| 500 |
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|a published: Print
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|a Citation Status MEDLINE
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| 520 |
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|a Copyright 2001 Academic Press.
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|a We are conducting a Phase I trial of a fusion toxin (DT-GM) for the treatment of relapsed or refractory acute myeloid leukemia (AML). The fusion toxin consists of a truncated diphtheria toxin (DT) linked to human granulocyte-macrophage colony stimulating factor (GM). Prior to beginning the Phase I trial, our first goal was to determine whether healthy controls and adult AML patients had preexisting antibodies able to inhibit DT-GM. Sera from 5 of the 9 controls completely neutralized DT-GM by an in vitro bioassay to assess the inhibition of DT-GM. Sera from 43 patients with AML were tested by bioassay and a specific enzymoimmunoassay (EIA) for anti-DT-GM antibodies. Forty-two of 43 samples were positive by EIA, and 5 patients (11.6%) showed complete neutralization of DT-GM in the bioassay. Anti-DT-GM concentrations were significantly higher in samples demonstrating neutralization than in samples demonstrating no neutralization (P = 0.003). In the Phase I trial of DT-GM prior to therapy, none of 28 patients exhibited neutralization by bioassay, but 89% were positive by EIA. After the first course of DT-GM, 23% developed neutralizing antibodies by the bioassay, and 64% of patients exhibited an increase in their anti-DT-GM antibody concentrations by EIA. Further studies are needed to determine the clinical impact of the anti-DT-GM antibodies and whether the neutralization bioassay can be replaced by our EIA
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| 650 |
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4 |
|a Clinical Trial
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| 650 |
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4 |
|a Clinical Trial, Phase I
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| 650 |
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4 |
|a Journal Article
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| 650 |
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4 |
|a Research Support, Non-U.S. Gov't
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| 650 |
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4 |
|a Research Support, U.S. Gov't, P.H.S.
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| 650 |
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7 |
|a Antibodies
|2 NLM
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| 650 |
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7 |
|a Diphtheria Toxin
|2 NLM
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| 650 |
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7 |
|a Recombinant Fusion Proteins
|2 NLM
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| 650 |
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7 |
|a Granulocyte-Macrophage Colony-Stimulating Factor
|2 NLM
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| 650 |
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7 |
|a 83869-56-1
|2 NLM
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| 700 |
1 |
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|a Virella, G
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Willoughby, T
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Atchley, D H
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Kreitman, R J
|e verfasserin
|4 aut
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| 700 |
1 |
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|a Frankel, A E
|e verfasserin
|4 aut
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| 773 |
0 |
8 |
|i Enthalten in
|t Clinical immunology (Orlando, Fla.)
|d 1999
|g 100(2001), 2 vom: 11. Aug., Seite 191-7
|w (DE-627)NLM098196855
|x 1521-7035
|7 nnns
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| 773 |
1 |
8 |
|g volume:100
|g year:2001
|g number:2
|g day:11
|g month:08
|g pages:191-7
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| 912 |
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|a GBV_USEFLAG_A
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| 912 |
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|a SYSFLAG_A
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| 912 |
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|a GBV_NLM
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| 912 |
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|a GBV_ILN_11
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| 912 |
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|a GBV_ILN_24
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| 912 |
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|a GBV_ILN_350
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| 951 |
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|a AR
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| 952 |
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|d 100
|j 2001
|e 2
|b 11
|c 08
|h 191-7
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