Protein-Tyrosine Kinase Inhibitor (STI571) for Treatment of Patients With Ph+ Chronic Myeloid Leukemia in Accelerated and Blastic Phase

Summary

This is a phase II, multi-center, open-label, non-randomized trial. During Part 1 of the trial, patients will receive once daily oral administration of STI571 at a dose of 600 mg for 24 weeks. After completing 24 weeks of therapy, patients may be eligible to receive additional therapy during Part 2 of the trial provided that, in the opinion of the investigator, the patient has benefited from treatment with STI571 and in the absence of safety concerns. During Part 2 (which is of indefinite duration), patients will continue to receive STI571 on a daily basis until either death, the development of intolerable toxicity or the investigator feels it is no longer in the patient's best interest to continue therapy, whichever comes first.

Timeline

Start

2000-08

Primary completion

—

Completion

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Publications

• Palandri F, Castagnetti F, Testoni N, Luatti S, Marzocchi G, Bassi S, Breccia M, Alimena G, Pungolino E, Rege-Cambrin G, Varaldo R, Miglino M, Specchia G, Zuffa E, Ferrara F, Bocchia M, Saglio G, Pane F, Alberti D, Martinelli G, Baccarani M, Rosti G; GIMEMA Working Party on Chronic Myeloid Leukemia. Chronic myeloid leukemia in blast crisis treated with imatinib 600 mg: outcome of the patients alive after a 6-year follow-up. Haematologica. 2008 Dec;93(12):1792-6. doi: 10.3324/haematol.13068. Epub 2008 Oct 6.

Drugs

Indications