ABL1/PDGFRB Rearrangemennt Positive Ph-like Acute Lymphoblasic Leukemia
Conditions
Interventions
Taking orally of Dasatinib 60mg per square meter body surface area once a day for two weeks
Sponsors
National Center for Child Health and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) primary refractory or relapsed ALL 2) ABL1 or PDGFRB Rearrangemennt is confirmed by FISH or PCR method 3) relapsed cases: over 25% blasts in bone-marrow at the time of study enrollment refractory cases: over 5% blasts in bone-marrow at the time of study enrollment 4) without history of previous chemotherapy after diagnosis of primary refractory or relapse (other than steroids within 10 days or intrathecal infusion) 5) Age 1 year to 20 years old at the time of study enrollment 6) ECOG performance status (PS) score of 0-2 7) Patients must have sufficient organ function 8) All patients and/or their parents or legal guardians must sign a written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with severe CNS or gastrointestinal hemorrhage (grade 2 or higher in CTCAE ver4.0) 2) Patients with severe fluid retention (grade 2 or higher in CTCAE ver4.0) 3) QTc is more than 0.45 seconds 4) Patients with uncontrollable infection (including those with active tuberculosis or positive HIV antibody) 5) Patient with a history of organ transplantation other than stem cell transplantation 6) Patient with uncontrollable diabetes mellitus 7) Patients with history of primary or acquired immunodeficiency 8) Patients who are pregnant 9) Patient with 21-trisomy 10) Patient with severe mental retardation 11) Patients with any other inappropriate status judged by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxic effects of dasatinib at the dose of 60 mg per square meter body surface area | — |
Secondary
| Measure | Time frame |
|---|---|
| - decay rate of blasts in peripheral blood - decay rate of blasts in bone-marrow blood - achievement rate of complete remission - PK study of dasatinib - TKI sensitivity test in vitro | — |
Countries
Japan
Contacts
Public ContactTomoo Osumi
National Center for Child Health and Development Division of Leukemia and lymphoma, Children's Cancer Center
Outcome results
None listed