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Randomized trial of two schedules of low-dose gemtuzumab ozogamicin as induction monotherapy for newly diagnosed acute myeloid leukemia in older patients not considered candidates for intensive chemotherapy. A phase II study of the EORTC and GIMEMA leukemia groups (AML-19)

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Randomized trial of two schedules of low-dose gemtuzumab ozogamicin as induction monotherapy for newly diagnosed acute myeloid leukemia in older patients not considered candidates for intensive chemotherapy. A phase II study of the EORTC and GIMEMA leukemia groups (AML-19)

Content Provider	PubMed Central
Author	Amadori, Sergio Suciu, Stefan Dominik, Selleslag Stasi, Roberto Giuliana, Alimena Baila, Liliana Rizzoli, Vittorio Borlenghi, Erika Gaidano, Gianluca Magro, Domenico Torelli, Giuseppe Muus, Petra Venditti, Adriano Cacciola, Emma Lauria, Francesco Marco, Vignetti Witte, Theo De
Abstract	This study compared two schedules of low-dose gemtuzumab ozogamicin (GO) as induction monotherapy for untreated acute myeloid leukemia in older patients unfit for intensive chemotherapy, to identify the more promising regimen for further study. Patients were randomized to receive either best supportive care or a course of GO according to one of two schedules: 3 mg/m2 on days 1, 3 and 5 (arm A), or GO 6 mg/m2 on day 1 and 3 mg/m2 on day 8 (arm B). Primary endpoint was the rate of disease non-progression (DnP), defined as the proportion of patients either achieving a response or maintaining a stable disease following GO induction in each arm. Fifty-six patients were randomized in the two GO arms (A, n=29; B, n=27). The rate of DnP was 38% (90% confidence interval [CI], 23%–55%) in arm A, and 63% (90% CI, 45%–78%) in arm B. Peripheral cytopenias were the most common adverse events for both regimens. The all-cause early mortality rate was 14% in arm A and 11% in arm B. The day 1+8 schedule, which was associated with the highest rate of DnP, met the statistical criteria to be selected as the preferred regimen for phase III comparison with best supportive care.
Related Links	http://dx.doi.org/10.1111/j.1365-2141.2010.08095.x
Ending Page	382
Page Count	7
Starting Page	376
File Format	PDF
ISSN	00071048
e-ISSN	13652141
Journal	British journal of haematology
Issue Number	3
Volume Number	149
Language	English
Publisher Date	2010-05-01
Access Restriction	Open
Subject Keyword	Hematology Research in Higher Education
Content Type	Text
Resource Type	Article
Subject	Hematology

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4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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