Philadelphia-chromosome positive acute lymphoblastic leukaemia
Conditions
Interventions
Experimental group:Inotuzumab ozogamicin, dasatinib in combination with VP regimen as inductive therapy, and then dasatinib + CAM/MA regimen as consolidation treatment, TKI as maintenance treatment
Sponsors
The Affiliated Tai'an City Central Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
14 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed untreated Ph-positive acute lymphoblastic leukemia confirmed by cell morphology and immunophenotype (except for prednisone and hydroxyurea use); 2. Age>=14 years old, =3 months; 5. Male and female who may have children consent and use effective contraception; 6. Evaluation criteria for major organ functions: total bilirubin (TBIL) 45%; 7. Understand and sign the informed consent form, agreeing to comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Burkitt lymphoma/leukemia; 2. Acute leukemia of unknown series; 3. Pregnant females; 4. Severe uncontrolled active infection; 5. Patients with a history of pancreatitis in the past; 6. Poorly controlled diabetes mellitus, defined as glycosylated hemoglobin value > 7.5%. Patients with pre-existing but well-controlled diabetes do not need to be excluded; 7. Patients with a history of active gastrointestinal bleeding in the past 6 months; 8. History of arterial/venous thrombosis within the past 6 months; 9. Known serum HIV positivity; 10. Psychiatric illness that may prevent the subject from completing treatment or informed consent; 11. Other conditions that are considered unsuitable for this study as assessed by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease free survival;Relapse free survival;Cumulative relapse frequencies;Treatment-related toxicity; | — |
Countries
China
Contacts
Public ContactQingliang Teng
The Affiliated Tai'an City Central Hospital of Qingdao University
Outcome results
None listed