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Blood, 1 March 2008, Vol. 111, No. 5, pp. 2581-2588.
Prepublished online as a Blood First Edition Paper on January 2, 2008; DOI 10.1182/blood-2007-08-107482.


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Submitted August 16, 2007
Accepted December 14, 2007

Dose finding study of imatinib in combination with intravenous cytarabine: feasibility in newly diagnosed patients with chronic myeloid leukemia

Wendy Deenik, Bronno van der Holt, Gregor E.G. Verhoef, Willem M. Smit, Marie J. Kersten, Hanneke C Kluin-Nelemans, Leo F Verdonck, Augustin Ferrant, Anton V.M.B. Schattenberg, Jeroen J.W.M. Janssen, Pieter Sonneveld, Marinus van Marwijk Kooy, Shulamit Wittebol, Roelof Willemze, Pierre W. Wijermans, Petra H.M. Westveer, H. Berna Beverloo, Peter Valk, Bob Lowenberg, Gert J. Ossenkoppele, and Jan J. Cornelissen*

Erasmus University Medical Center, Rotterdam, Netherlands
University Hospital Gasthuisberg, Leuven, Belgium
Medical Spectrum Twente, Enschede, Netherlands
Hematology, Academic Medical Center, Amsterdam, Netherlands
University Hospital Groningen, Groningen, Netherlands
University Medical Center Utrecht, Utrecht, Netherlands
University Hospital St-Luc, Brussels, Belgium
Radboud University Nijmegen Medical Center, Nijmegen, Netherlands
VU Medical Center, Amsterdam, Netherlands
Isala Clinic-Sophia, Zwolle, Netherlands
Meander Medical Center, Amersfoort, Netherlands
Leiden University Medical Center, Leiden, Netherlands
Haga Hospital, The Hague, Netherlands

* Corresponding author; email: j.cornelissen{at}erasmusmc.nl.

The HOVON cooperative study group performed a feasibility study of escalated imatinib and intravenous cytarabine in 165 patients with early chronic phase chronic myeloid leukemia (CML). Patients received two cycles of intravenous cytarabine (200 mg/m2 or 1000 mg/m2 days 1-7) in conjunction with imatinib (200 mg, 400 mg, 600 mg or 800 mg), according to predefined, successive dose levels. All dose levels proved feasible. Seven dose limiting toxicities (DLTs) were observed in 302 cycles of chemotherapy, which were caused by streptococcal bacteremia in five cases. Intermediate-dose cytarabine (1000 mg/m2) prolonged time to neutrophil recovery and platelet recovery as compared to a standard-dose (200 mg/m2). High-dose imatinib (600 mg or 800 mg) extended the time to platelet recovery as compared to a standard-dose (400 mg). More infectious complications common toxicity criteria (CTC) grade 3-4 were observed after intermediate-dose cytarabine as compared to a standard-dose of cytarabine. Early response data after combination therapy included a complete hematologic cytogenetic response in 48% and a major molecular response in 30% of patients, which increased to 46% major molecular responses at 1 year, including 13% complete molecular responses. We conclude that combination therapy of escalating dosages of imatinib and cytarabine is feasible. This study was registered at www.kankerbestrijding.nl as #CKTO-2001-03.


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T. P. Hughes, S. Branford, D. L. White, J. Reynolds, R. Koelmeyer, J. F. Seymour, K. Taylor, C. Arthur, A. Schwarer, J. Morton, et al.
Impact of early dose intensity on cytogenetic and molecular responses in chronic- phase CML patients receiving 600 mg/day of imatinib as initial therapy
Blood, November 15, 2008; 112(10): 3965 - 3973.
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