A phase I, multicenter, open-label study of oral ABL001 in patients with chronic myelogenous leukemia or Philadelphia Chromosome-positive acute lymphoblastic Leukemia (CABL001X2101) - CABL001X2101

ovartis0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•Male or female patients at least 18 years of age.
•CML in chronic or accelerated phase who were previously treated with two
•different tyrosine kinase inhibitors prior to study entry and are relapsed,
•refractory to or intolerant of TKIs as determined by investigators
•Philadelphia chromosome-positive ALL and be relapsed or refractory to one prior
•TKI or intolerant of TKIs.
•See protocol page 26-27 for further details.
•ECOG performance status 0-2.

•Systemic antineoplastic therapy or any experimental therapy within 14 days or
•5 half-lives, whichever is longer, before the first dose of ABL001
•For patients receiving ABL001 in combination with either nilotinib, or imatinib
•or dasatinib, intolerance to nilotinib, imatinib or dasatinib, respectively
•Radiotherapy within 1-4 weeks of the first dose of ABL001. See protocol page
•27 for details.
•CNS irradiation for meningeal leukemia, except if radiotherapy occurred > 3
•months previously.
•Clinical laboratory results: see protocol page 27-28.
•Active infection.
•History of significant bleeding disorder unrelated to cancer.
•History of acute pancreatitis within 1 year of study entry, chronic
•pancreatitis, or any ongoing pancreatic disease not considered related to the
•malignancies under study.
•Pregnant or lactating women.
•Women of child-bearing potential using inadequate contraception. See protocol
•page 28-29 for details.
•Males in arm 4 must use a condom during intercourse while taking the drug and
•for 30 days after stopping treatment and should not father a child in this

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