Acute B lymphoblastic leukemia (ALL)
Conditions
Interventions
Trail Group:Blinatumomab
Control group:Standard chemotherapy regimens for newly diagnosed adult Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia (Ph-negative B-ALL)
Sponsors
Henan Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed Philadelphia chromosome-negative B-ALL patients confirmed by MICM classification according to WHO diagnostic criteria; 2. Age: 18–70 years old (including 18 and 70 years old); 3. No restriction on gender; 4. ECOG performance status score: 0–3; 5. Expected survival time >= 3 months; 6. Liver function: total bilirubin = 30 mL/min; 8. Patients fully understand and voluntarily participate in this study, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Combined central nervous system leukemia; 2. Acute mixed phenotypic leukemia; 3. MRD-positive B-cell acute lymphoblastic leukemia; 4. Philadelphia chromosome-positive B-ALL; 5. Active hepatitis B or hepatitis C infection; 6. Severe pulmonary, cardiac, hepatic or renal diseases; 7. Pregnant or lactating females, as well as females of childbearing potential without effective contraception; 8. Patients with severe autoimmune diseases, psychiatric disorders or cognitive impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRD negative conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| - to 2-year disease-free survival (DFS);Overall Survival (OS);CR/CRh (Complete remission with incomplete hematologic recovery);Incidence of grade >=3 infections during induction therapy;Quantitative score of quality of life;Duration of myelosuppression; | — |
Countries
China
Contacts
Public ContactQingsong Yin
Henan Cancer Hospital
Outcome results
None listed