Philadelphia chromosome -negative acute lymphoblastic leukemia
Conditions
Interventions
Expereimental group:Bcl-2 inhibitor combined with Blinatumomab
Control group:Pediatric-inspired multiagent chemotherapy
Sponsors
The Second Affiliated Hospital of the Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and<65 years; 2. The immunophenotype(CD19 positivity)and molecular test with bone marrow or peripheral blood must be completed before enrollment in order to diagnose the Philadelphia chromosome-negative acute lymphoblastic leukemia according to the 2022 WHO. Notes: Philadelphia chromosome-negativity must be confirmed by cytogenetics, fluorescence in situ hybridization, and polymerase chain reaction. If it is negative for Philadelphia chromosome, the fluorescence in situ hybridization or polymerase chain reaction must be performed in order to exclude the cryptic or rare translocation; 3. The patients had not received the induction treatment (excluding the hydroxyurea and less five days for glucocorticoid ); 4. ECOG performance status of <=2 at study entry; 5. Understand and voluntarily sign an informed consent form; 6. Serum creatinine<=1.5 upper limit of normal before 48 h of enrollment. Notes: If the abnormal creatinine is caused by leukemia, this term is not available; 7. Liver: ALT/AST < 3 x the upper limit of normal and total bilirubin <=1.5 upper limit of normal before 48 h of enrollment Notes: If the abnormal function is caused by leukemia, this term is not available; 8. The negativity for urine pregnancy test must be confirmed for child-bearing women; 9. Reliabel contraception must be confirmed before enrollment, during treatment, and after four months after treatment.
Exclusion criteria
Exclusion criteria: 1. mixed lineage leukemia; 2. Central nervous system leukemia; 3. Disease with dysfunction of heart, lung, liver and kidney including but not limited to serious infection, uncontrolled diabetes, uncontrolled hypertension?, serious cardiac insufficiency (LVEF<50%) or angina pectoris, active pulmonary tuberculosis, asthma, chronic obstructive pulmonary disease, bronchiectasis; (1).History with myocardial Infarction within 3months, uncontrolled congestive heart failure or arrhythmia; (2).Central nervous system disease in the past or present including epilepsy with degree 2 or over in the present, seizures, numb, aphasia?, clinically relevant stroke, severe brain injury, dementia, parkinson's disease, organic brain syndrome, psychosis. 4. History with other malignant tumor in the past five years including but not limited to local thyroid cancer, skin carcinoma in situ.; 5. HIV infection ; 6. Pregnant or lactating women;Man should understand the fertility risk and take effectively methods of contraception 7. Received treatment of the monoclonal antibody, chemotherapy excluding induction treatment, and radiotherapy before two weeks of enrollment; 8. Allergy to immunoglobulins or any other component of the study drugs; 9. Patients that can’t be enrolled which will be judged by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of minimal residual disease negativity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of infection;Overall response rate;1-year disease free survival;Health related quality of life;The rate of minimal residual disease negativity of NGS;1-year overall survival;Duration of response;Hematologic toxicity; | — |
Countries
China
Contacts
Public ContactCheng Zhang
The Second Affiliated Hospital of the Army Medical University
Outcome results
None listed