Ph(+) Acute Lymphatic Leukemia
Conditions
Interventions
Group A (experimental group):On the 8th (±3) day of induction chemotherapy, 600 mg qd of imatinib was started and continued treatment for 90 days, and then replaced with dasatinib 70 mg bid for 90 day
Group B (control group):Start imatinib 600 mg qd on the 8th (±3) day of induction chemotherapy until drug resistance occurs, and change the appropriate TKI drug according to the mutation type
Sponsors
Tongji Hospital of Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Between 18 and 75 years old; 2. ECOG physical strength 0-2 points; 3. The treatment institution conducts a pathological examination of the subjects, and the diagnosis results meet the Ph-positive acute lymphoblastic leukemia classified by the World Health Organization; 4. Main organ function evaluation standards: total bilirubin=45%); 5. Patients must have the following laboratory values (>= 1 ULN) or supplement treatment to the normal range before being selected for this study: blood potassium >=1 ULN; blood magnesium >=1 ULN; blood phosphorus >= 1 ULN; 6. Men and women who may have children agree to and take effective contraceptive measures; 7. After evaluation by the investigator, the subject is deemed suitable for the pre-selected combination chemotherapy; 8. Subjects are suitable for oral TKI drugs; 9. A written informed consent has been signed; 10. The subject agrees not to participate in other interventional studies during the treatment period; 11. Before conducting any research-related procedures (including stopping banned drug treatment, if applicable), the subject or legal representative should sign an informed consent form approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) and comply with the state The confidentiality clause of the regulations.
Exclusion criteria
Exclusion criteria: 1. Patients with severe organic disease or failure of important organs, such as decompensated heart, liver, lung, and kidney failures that cannot tolerate treatment, and patients with uncontrollable severe infections; 2. Gene mutation detection before treatment for patients with bcr or abl gene mutations; 3. Women or male patients of childbearing age who cannot use adequate methods for contraception, including pregnant or lactating women; 4. Have a clear history of neurological or mental disorders, including epilepsy or dementia; 5. Use other clinical trial drugs within 30 days; 6. Patients with other malignant tumor diseases; 7. According to the judgment of the investigator, there are accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study; 8. Those who are known or suspected to be allergic to this type of preparation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall incidence of resistance;Median time of first onset of resistance;Types of acquired resistance;Reversal of acquired resistance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Complete response rate (CR);bcr/abl fusion gene quantitative expression level;12 months major molecular response (MMR);12 months complete cytogenetic response (CCyR);Molecular response (3 months, 6 months, 12 months); | — |
Countries
China
Contacts
Public ContactFu Jian-fei
Tongji Hospital of Tongji University
Outcome results
None listed