This is a prospective, multicenter, observational study aimed at exploring the efficacy and safety of reduced-dose chemotherapy followed by frontline therapy with blinatumomab in patients aged 15-65 with newly diagnosed Ph-negative B-ALL.
The 14-day blinatumomab combined with reduced-dose chemotherapy is used for the induction treatment of newly diagnosed Ph-chromosome negative acute B-lymphoblastic leukemia. On day 14, an intrathecal injection of chemotherapy is administered; on days 28-35, bone marrow is assessed, and patients who do not achieve complete remission are withdrawn from the study. Patients with positive minimal residual disease (MRD) after induction treatment undergo transplant typing and proceed to allogeneic hematopoietic stem cell transplantation (Allo-HSCT) after early intensification. Patients with negative MRD receive alternating treatment with multi-drug combination chemotherapy and blinatumomab, for a total of 8 consolidation courses, including 3 courses of blinatumomab. Maintenance therapy lasts for at least 18 months, using the POMP regimen with or without one cycle of blinatumomab every six months. Throughout the entire treatment phase, at least 12 preventive intrathecal injections are administered.
Study Type
OBSERVATIONAL
Enrollment
36
The 14-day blinatumomab combined with reduced-dose chemotherapy is used for the induction treatment of newly diagnosed Ph-chromosome negative acute B-lymphoblastic leukemia.
The overall response rate
The overall response rate after induction therapy = Complete Remission (CR) + CR with partial hematologic recovery (CRh) + CR with incomplete hematologic recovery (Cri).
Time frame: At the end of induction treatment from day 28 to day 35
Minimal Residual Disease (MRD) negativity rate after induction therapy
MRD negativity refers to a flow cytometry test result where MRD is less than 0.01%.
Time frame: At the end of induction treatment from day 28 to day 35
Complete molecular remission rate.
Complete molecular remission rate is defined as undetectable Ig rearrangement by next-generation sequencing, with a detection sensitivity of at least less than 10\^-5.
Time frame: At the end of induction treatment from day 28 to day 35
One-year overall survival rate.
The proportion of patients who are still alive one year after the date of disease diagnosis, out of the total number of subjects enrolled in the study.
Time frame: From diagnosis of the disease to the end of the first year
One-year event-free survival rate
The proportion of patients who have not experienced disease progression, been diagnosed with another cancer, or died from any cause one year after the date of disease diagnosis, out of the total number of subjects enrolled in the study.
Time frame: From diagnosis of the disease to the end of the first year
Safety
Safety endpoints are defined, graded, and evaluated according to the CTCAE version 5.0 criteria.
Time frame: From enrollment until withdrawal from the study or the end of follow-up up to two years
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