Pilot Late Phase II Study of KRN8602 (MX2), a Novel Anthracycline Derivative, for Acute Leukemia. A Dose Finding Study in Combination.
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Accession number;99A0203859
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| Title;Pilot Late Phase II Study of KRN8602 (MX2), a Novel Anthracycline Derivative, for Acute Leukemia. A Dose Finding Study in Combination. |
| Author;
HIRAOKA AKIRA
(Osakafubyoinbyose)
SAMPI KAZUMI
(Shiraoichokokuhobyoin)
KURAISHI YASUNOBU
(Jikei Univ. School of Medicine)
TAKEMOTO YOSHINOBU
(Hyogo Coll. of Med.)
OKABE KEN'ICHI
(National Shikoku Cancer Center Hospital)
TAMURA KAZUO
(Fukuoka Univ., Fac. of Med.)
OGAWA KAZUMASA
(Aichi Cancer Center)
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Journal Title;Japanese Journal of Cancer and Chemotherapy
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Journal Code:Z0938A
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ISSN:0385-0684
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VOL.26;NO.1;PAGE.93-99(1999)
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| Figure&Table&Reference;TBL.6, REF.9 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;In order to determine the clinically optimal dose of KRN8602, a new anthracycline derivative, in combination therapy for acute leukemia, we performed a pilot late phase II study in combination with cytarabine (Ara-C) for acute myelogenous leukemia(AML), and with vincristine(VCR) and prednisolone(PSL) for acute lymphocytic leukemia(ALL). KRN8602 was given at a dose of 12 or 15mg/m2 for 5 consecutive days, Ara-C at a dose of 100mg/m2 for 7 consecutive days, VCR 1.4mg/m2 (max. 2.0mg/body) weekely for 4 weeks, and PSL 40mg/m2 for principally 28 consecutive days. Of 14 patients with relapsed or refractory leukemia entered in the study, thirteen patients were evaluable for safety and 12 were evaluable for response. In AML, there was 1 partial response(PR) in 4 patients at a dose of 12mg/m2. Against 1 complete response(CR) and 3 PRs in 4 patients at a dose of 15mg/m2. In ALL, there was 1 PR in 1 case at a dose of 12mg/m2, and 1 CR and 2 PR in 3 at a dose of 15mg/m2. Major toxicities were nausea/vomiting and anorexia, but incidences and grades of toxicities were not dose-dependent, and all toxicities were tolerable and manageable. From these results it is concluded that the optimal dose of KRN8602 is 15mg/m2 for 5 consecutive days in combination with Ara-C for AML, and with VCR and PSL for ALL. (author abst.) |
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