Philadelphia-chromosome negative acute lymphoblastic leukaemia
Conditions
Interventions
Patient group:Inotuzumab ozogamicin in combination with VP regimen as inductive therapy, and then dasatinib + CAM, MA(L) regimen as consolidation treatment. Then, according to MRD monitoring results a
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 Ph-negative acute lymphoblastic leukemia untreated (except prednisone and hydroxyurea use) confirmed by cell morphology and immunophenotype; 2.Age >=14 years old, = 3 months; 5. Men and women who may give birth agree to and use effective contraceptive methods; 6. Main organ function assessment criteria: total bilirubin (TBIL) 45% as shown by cardiac color ultrasound; 7. Understand and sign the informed consent and agree to comply with the study requirements;
Exclusion criteria
Exclusion criteria: 1.Burkitt lymphoma leukemia; 2. Unknown series of acute leukemia; 3. Pregnant women; 4. severe uncontrolled active infection; 5. Patients with previous history of pancreatitis; 6. Poorly controlled diabetes, defined as a hemoglobin A1C value > 7.5%. It is not necessary to exclude patients with pre-existing but well-controlled diabetes; 7. Patients with a history of active gastrointestinal bleeding within the last 6 months; 8. History of arterial/venous thrombosis within the last 6 months; 9. Known serum HIV positive; 10. A mental illness that is likely to prevent the subject from completing treatment or giving informed consent; 11. Other situations deemed unsuitable for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission rate;MRD negativity 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