None listed
Conditions
Interventions
Drug : 1. In newly diagnosed ALL patients, low-intensive chemotherapy and intrathecal methotrexate treatment are performed until Philadelphia chromosome results are identified, and preparation for all
Sponsors
Kyungpook National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women over 19 years of age A patient with newly diagnosed Philadelphia chromosome positive B-cell acute lymphoblastic leukemia Patients who have not previously been treated for acute lymphoblastic leukemia Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2 Patients who have a donor for allogeneic hematopoietic stem cell transplantation and are in a condition suitable for transplantation When the Philadelphia chromosome or BCR-ABL gene is confirmed in a bone marrow test Patients who wish to voluntarily participate in clinical trials and do not have difficulty swallowing capsules In cases where a negative urine hCG test is confirmed before treatment in women of childbearing age Patients who must use at least two methods of contraception, including one highly effective method, during the treatment period and up to 6 months after the end of treatment Patients who understand the purpose and risks of the clinical trial, are willing and able to sign a consent form for the clinical trial, are cooperative with the clinical trial, and are judged to be able to participate until the end of the trial. Patients with adequate liver, kidney, and heart function
Exclusion criteria
Exclusion criteria: Patients diagnosed as Philadelphia chromosome negative Patients who had been treated for Philadelphia chromosome-positive acute lymphoblastic leukemia prior to clinical trials If you have a history of other cancer treatment or are currently diagnosed with cancer that requires treatment (except appropriately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or if there has been no recurrence for more than 3 years after the end of cancer treatment) Patients with uncontrolled hypertension despite appropriate medical measures, uncontrolled or symptomatic arrhythmia, congestive heart failure, or myocardial infarction within 6 months at the time of screening, or New York Heart Association Functional Classification stage 3 or 4 heart disease Patients taking medications known to be at risk for QTc prolongation or torsade de pointes (TdP) Patients with a history of clinically significant, uncontrolled, or active cardiovascular, cerebrovascular, or peripheral vascular disease, or active venous thromboembolism If the patients have a history of HIV infection or an uncontrolled systemic infection (bacterial, viral, fungal infection, etc.) Diseases related to the central nervous system (seizure, paresis, aphasia, cerebrovascular ischemia/haemorrhage, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder, etc.) require treatment or require treatment within 6 months. If you have a history of receiving If major surgical treatment was performed within 28 days prior to treatment (However, if major surgical treatment was performed, clinical trial registration is possible as long as there is adequate recovery from complications or side effects.) Hepatitis B and Hepatitis C: If Hepatitis B core antibody is positive and surface antigen is negative, a negative result must be confirmed in the PCR test. Patients who are positive for hepatitis B surface antigen or positive for hepatitis B PCR are excluded from clinical trials. Patients who are positive for hepatitis B core antibody and negative for surface antigen and hepatitis B PCR must receive appropriate preventive treatment for hepatitis B during the treatment period. If the patient is positive for Hepatitis C antibody, the result must be negative in PCR. If Hepatitis C PCR is positive, you will be excluded from the clinical trial. If the patients are breastfeeding or pregnant If the patietns are participating in another study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission [CR] rate after allogeneic stem cell transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of minimal residual disease (MRD)-negative complete response after allogeneic stem cell transplantation | — |
Countries
Korea, Republic of
Contacts
Public ContactSang Kyun Sohn
Kyungpook National University Hospital
Outcome results
None listed