A Pilot Study of Dasatinib for Relapsed or Refractory ABL1/PDGFRB Rearrangemennt Positive Ph-like Acute Lymphoblasic Leukemia
Not Applicable
Recruiting
- Conditions
- ABL1/PDGFRB Rearrangemennt Positive Ph-like Acute Lymphoblasic Leukemia
- Registration Number
- JPRN-UMIN000016494
- Lead Sponsor
- ational Center for Child Health and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Toxic effects of dasatinib at the dose of 60 mg per square meter body surface area
- Secondary Outcome Measures
Name Time Method - 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