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International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Ph+ ALL Testing Imatinib in Combination with Two Different Cytotoxic Chemotherapy Backbones
The purpose of this research study is to look at how well the use of a TKI (tyrosine kinase inhibitor), called imatinib, works when given to
children and young adults with high risk (HR) Ph+ ALL with a combination chemotherapy prior to stem cell transplant (SCT), and when imatinib is given alone after SCT. Imatinib therapy after SCT is considered to be experimental
Phase 3 Trial for Philadelphia chromosome-positive acute lymphoblastic leukemia Imatinib in Combination with Two Different Backbones
Greater than 1 year and less than 21 years at ALL diagnosis
Newly diagnosed de novo ALL (B-ALL or T-ALL) with definitive evidence of BCRABL1 fusion by karyotype, FISH and/or RT-PCR
Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2
Adequate liver, cardiac, and renal function
Sexually active patients of reproductive potential must agree to use an effective contraceptive method for the duration of their study participation
Known history of chronic myelogenous leukemia (CML).
ALL developing after a previous cancer treated with cytotoxic chemotherapy.
Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
Pregnancy and Breast Feeding
Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block.
Prior treatment with dasatinib, or any BCR-ABL1 inhibitor other than imatinib.
Applicable Disease Sites
Gundersen Health System; UW Hospital and Clinics