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A phase I/II study ...
A phase I/II study of the MDR modulator Valspodar (PSC 833) combined with daunorubicin and cytarabine in patients with relapsed and primary refractory acute myeloid leukemia
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Gruber, A (author)
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- Björkholm, M (author)
- Karolinska Institutet
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Brinch, L (author)
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Evensen, S (author)
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Gustavsson, B (author)
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Hedenus, M (author)
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- Juliusson, Gunnar, 1954- (author)
- Östergötlands Läns Landsting,Linköpings universitet,Hälsouniversitetet,Hematologi,Hematologiska kliniken US
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- Lofvenberg, E (author)
- Uppsala universitet,Institutionen för onkologi, radiologi och klinisk immunologi,Onko
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Nesthus, I (author)
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- Simonsson, B (author)
- Uppsala universitet,Institutionen för medicinska vetenskaper,Blodsjukdomar
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Sjö, M (author)
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- Stenke, L (author)
- Karolinska Institutet
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Tangen, JM (author)
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Tidefelt, U (author)
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Uden, AM (author)
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- Paul, C (author)
- Karolinska Institutet
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Liliemark, J (author)
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(creator_code:org_t)
- 2003
- 2003
- English.
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In: Leukemia Research. - 0145-2126 .- 1873-5835. ; 27, s. 323-
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https://doi.org/10.1...
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Abstract
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- The cyclosporine analog Valspodar (PSC 833, Novartis Pharma) is a strong inhibitor of the mdr1 gene product p-glycoprotein (pgp). A phase I/II study was conducted in order to evaluate if addition of Valspodar to treatment with daunorubicin and cytarabine, given to patients with primary refractory or relapsed acute myeloid leukemia, could increase the complete remission rate. Fifty-three patients were treated in cohorts of three to six patients. Twelve patients reached a complete remission in bone marrow, five of whom also normalized their peripheral blood values. Three patients experienced treatment-related deaths from pneumonia, liver failure and cerebral hemorrhage, respectively. It is concluded that Valspodar 10mg/kg per 24h in combination with daunorubicin 45mg/m2 for 3 days and cytarabine 1g/m2 twice daily for 4 days is tolerable in this heavily pre-treated group of patients. Due to the moderate treatment results, the phase II part of the study was ended prematurely. The modulation of only pgp did not give an obvious improvement of the treatment results in this group of patients. ⌐ 2002 Elsevier Science Ltd. All rights reserved.
Keyword
- MEDICINE
- MEDICIN
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Gruber, A
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Björkholm, M
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Brinch, L
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Evensen, S
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Gustavsson, B
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Hedenus, M
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show more...
-
Juliusson, Gunna ...
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Lofvenberg, E
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Nesthus, I
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Simonsson, B
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Sjö, M
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Stenke, L
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Tangen, JM
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Tidefelt, U
-
Uden, AM
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Paul, C
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Liliemark, J
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show less...
- Articles in the publication
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Leukemia Researc ...
- Leuk Res
- By the university
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Linköping University
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Karolinska Institutet
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Uppsala University