Philadelphia Chromosome-positive B-Acute Lymphoblastic Leukemia
Conditions
Interventions
Test group:OVB+Blina+VEN+Chemo-light regimen
Sponsors
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age older than 1 month to younger 18 years. 2. Bone marrow morphology diagnosis is acute lymphoblastic leukemia; 3. Immunologically classified as B-cell acute lymphoblastic leukemia; 4. Philadelphia chromosome (BCR-ABL1) fusion gene positive. 5. Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.
Exclusion criteria
Exclusion criteria: 1. ALL evolved from CML. 2. Known underlying congenital immunodeficiency or metabolic disease. 3. Congenital heart disease with cardiac insufficiency. 4. Gastrointestinal dysfunction or gastrointestinal diseases that may significantly alter the absorption of study drug. 5. Severe malnutrition, uncontrolled active infections, or serious cardiovascular diseases. 6. Subjects with significant CNS disorder (e.g., uncontrolled seizure disorder, autoimmune disease involving CNS). 7. Treated with glucocorticoids for >=14 days, or targeted inhibitor for > 7 days within one month before enrollment, or any chemotherapy or any systemic anticancer therapy (including but not limited to any TKI) or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression). 8. Any significant comorbidities or psychiatric disorders that may impact patient safety, compliance, informed consent, study participation, follow-up, or the interpretation of study results. In such cases, all participating sites must report directly to the PI to determine whether the patient meets exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal residual disease,MRD; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year event-free survival rate, EFS;pharmacokinetics;The rate of Grade 3 or above toxicities;Overall survival, OS;Cumulative incidence rate, CIR; | — |
Countries
China
Contacts
Public ContactXiaofan Zhu
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.
Outcome results
None listed