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Protocol No. AALL1631

Principal Investigator DeSantes, Kenneth

Phase III

Age Group Both

Scope National

Sponsor Type National

Title International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Ph+ ALL Testing Imatinib in Combination with Two Different Cytotoxic Chemotherapy Backbones

Objective 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

Description Phase 3 Trial for Philadelphia chromosome-positive acute lymphoblastic leukemia Imatinib in Combination with Two Different Backbones

Key Eligibility
  • 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
    Exclusion Criteria
  • 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
  • Down syndrome
  • 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 Leukemia

    Status Open

    Participating Institutions Gundersen Health System; UW Hospital and Clinics