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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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2003 (English)In: Leukemia research: a Forum for Studies on Leukemia and Normal Hemopoiesis, ISSN 0145-2126, Vol. 27, no 4, 323-328 p.Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2003. Vol. 27, no 4, 323-328 p.
National Category
Medical and Health Sciences
URN: urn:nbn:se:liu:diva-25165DOI: 10.1016/S0145-2126(02)00181-9Local ID: 9599OAI: diva2:245492
Available from: 2009-10-07 Created: 2009-10-07 Last updated: 2011-01-13

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Juliusson, Gunnar
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Faculty of Health SciencesHematologyDepartment of Haematology UHL
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Leukemia research: a Forum for Studies on Leukemia and Normal Hemopoiesis
Medical and Health Sciences

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