Ph+ALL
Conditions
Interventions
The dose increase and decrease judgment in the first and second cohort 1. Three patients are enrolled in the first cohort (level 1). If continuous administration successful execution is three of thre
Sponsors
Kanto Study Group for Cell Therapy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age at agreement acquisition between 18 and 65 years old (2) Patients with Ph+ALL, and underwent allogeneic hematopoietic stem cell transplantation (3) More than 100 days after transplant, and a donor blood corpuscle engraftin (4) Acute GVHD being less than GradeII In the test value within 7 days from registration, as the following; (5) Neutrophil count more than 1500/ (6) Platelet count more than 100,000/ (7) ECOG performance status being 0 or 1(8) Adequate end organ function being maintained 1. We meet the following standards with test value within 7th from a registration day 2. Total bilirubin < 5 x upper limit of normal, AST and ALT < 1.5 x upper limit of normal 3. Serum creatinine < 1.5 x upper limit of normal 4. More than 93% of percutaneous oxygen saturation (9) Pleural effusion do not be detected (in chest simplicity photograph or chest CT) (10) The agreement in the document being obtained from the person himself about participation in this study
Exclusion criteria
Exclusion criteria: (1) By the continuous use of insulin a case (diabetes that leaves when there is it more than 200 mg/dl of fasting blood glucose or) with the diabetes mellitus inadequate control (2) The patients with positive one of HBs antigen, HCV antibody, HIV antibodies (3) A case with hypertension that has poor control by the antihypertensive agent use (4) The case that develops the infection that is impossible of control (5) The case that develops sinusoid obstruction syndrome (SOS) (6) The case that develops the thrombotic microangiopathy (TMA) that is impossible of control (7) A case with the double cancer of the activity (8) The case with the mental disorder that it is thought to be difficult to obtain effective consent (9) It is a case with a history of the upper part, the lower digestive tract bleeding in the past (10) In addition, the case that attending staff judged to be inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is a continuous administration successful execution ratio after an administration for four weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) DLT frequencies (for initial four weeks each administration course, all administration course) (2) Adverse event frequencies (3) A continuous administration period (4) A complete molecular remission (complete molecular response) rate after the dasatinib administration (5) Overall survival one year later after transplantation (6) Recurrence rate one year later after transplantation (7) Pharmacokinetics | — |
Countries
Japan
Contacts
Public ContactMakoto Onizuka
Kanto Study Group for Cell Therapy Trial Office
Outcome results
None listed