This is a prospective, open-label, single-arm, umbrella phase 2 clinical trial enrolling 22 adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) B-cell acute lymphoblastic leukemia (ALL). As an umbrella trial, all patients share the same target disease (newly diagnosed Ph+ B-ALL) and receive a uniform induction backbone consisting of multi-targeted immunotherapy, targeted therapy, and reduced-intensity chemotherapy. After induction, patients are stratified and assigned to two distinct consolidation pathways based on clinical condition, performance status, resource availability, and patient preference: Pathway A: Consolidation with CD19-directed CAR-T cell therapy to achieve deep molecular remission; Pathway B: Consolidation with sequential immunochemotherapy to maximize minimal residual disease (MRD) clearance. A backup chemotherapy backbone is provided for patients ineligible for antibody therapy. All patients, regardless of consolidation pathway, proceed to a unified long-term maintenance regimen. The primary endpoint is the complete molecular remission (CMR) rate after one cycle of induction therapy. MRD is monitored longitudinally by flow cytometry, quantitative PCR, and immune repertoire sequencing. Safety is evaluated per NCI CTCAE version 5.0.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Third-generation tyrosine kinase inhibitor (TKI) targeting BCR::ABL1, administered orally daily as part of induction, consolidation, and maintenance therapy.
BCL-2 inhibitor administered orally daily during induction and consolidation cycles to enhance leukemic cell apoptosis.
Anti-CD22 antibody-drug conjugate (ADC) administered intravenously during induction and consolidation therapy.
CD19/CD3 bispecific T-cell engager (BiTE) administered as continuous intravenous infusion during consolidation therapy.
Autologous CD19 CAR-T cell therapy administered as a single intravenous infusion as optional consolidation therapy for eligible patients.
Chinese Academy of Medical Sciences Hospital of Hematology (Chinese Academy of Medical Sciences Institute of Hematology)
Tianjin, Tianjin Municipality, China
Complete Molecular Remission (CMR) Rate After 1 Cycle of Induction Therapy
The proportion of patients achieving complete molecular remission (CMR), defined as undetectable BCR::ABL1 transcript by quantitative PCR (BCR::ABL1/ABL1 ratio \< 0.001%), after 1 cycle of induction therapy.
Time frame: At the end of Cycle 1 (each cycle is 28 days, approximately 4 weeks from enrollment)
3-Month Complete Remission (CR)
Time frame: 3 months after study enrollment
3-Month MRD Negativity Rates
Time frame: 3 months after study enrollment
2-Year Overall Survival (OS)
OS is defined as the time from study enrollment to death from any cause.
Time frame: 2 years after the last patient enrollment
2-Year Disease-Free Survival (DFS)
DFS is defined as the time from study enrollment to disease relapse or death from any cause.
Time frame: 2 years after the last patient enrollment
2-Year Event-Free Survival (EFS)
EFS is defined as the time from study enrollment to first occurrence of predefined adverse events, disease progression or death.
Time frame: 2 years after the last patient enrollment
Incidence of Treatment-Related Adverse Events (TRAEs)
Number and severity of adverse events graded according to NCI CTCAE version 5.0.
Time frame: From study enrollment to 60 days after the last treatment
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