This is a prospective, open-label, single-arm, two-cohort Phase 2 clinical study designed to evaluate the efficacy and safety of Bcl-2 Inhibitor combined with azacitidine (with blinatumomab added in B/myeloid subtype) in patients with newly diagnosed mixed phenotype acute leukemia (MPAL). Eligible subjects are divided into two cohorts based on immunophenotype: Cohort A (T/Myeloid MPAL) receives Bcl-2 Inhibitor + azacitidine, and Cohort B (B/Myeloid MPAL) receives Bcl-2 Inhibitor + azacitidine + blinatumomab. The treatment cycle is 28 days, with the primary efficacy endpoint assessed after 2 cycles of induction therapy. Patients who achieve CRc will undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) following 2 to 3 cycles of consolidation therapy.The total enrollment period is 24 months, and all subjects will be followed up for at least 24 months from the first day of the first cycle (C1D1).
The primary objective is to evaluate the composite complete response (CRc) rate after 2 cycles of induction therapy , and the secondary objectives include evaluating measurable residual disease (MRD) negativity rate, bridge-to-allogeneic hematopoietic stem cell transplantation (allo-HSCT) rate in first complete response (CR1), overall survival(OS),Event-Free Survival(EFS),Relapse-Free Survival(RFS) and Safety.
Aged 16 to 70 years old
Newly diagnosed MPAL confirmed by the 2022 WHO/ICC classification criteria for hematopoietic and lymphoid neoplasms
Previously untreated; use of glucocorticoids or hydroxyurea for ≤7 days to control tumor burden before enrollment is allowed, no other systemic anti-leukemia therapy
ECOG performance status score 0-3
BCR::ABL-positive MPAL patients
Presence of active, uncontrolled infection
Known uncontrolled active central nervous system leukemia (CNSL)
Life-threatening extramedullary disease requiring urgent radiotherapy or surgical debulking
Parallel
BCL-2 indibitor
DrugSonrotoclax:40mg qd (D1), 80mg qd (D2), 160mg qd (D3), 320mg qd (D4-D21), oral; * 2 cycles.
Azacitidine (AZA)
Drug75mg/m² qd (D1-D7), subcutaneous injection; 28-day cycle, ≥2 cycles
Blinatumomab
Drug9μg/day (D8-D14), 28μg/day (D15-D21), continuous intravenous infusion
Composite Complete Response (CRc) rate after 2 cycles of induction therapy
CRc = CR + CRi; CR: bone marrow blasts \<5%, no extramedullary disease, no peripheral blasts, ANC ≥1.0×10⁹/L, PLT ≥100×10⁹/L; CRi: bone marrow blasts \<5%, no extramedullary disease, no peripheral blasts, incomplete hematologic recovery (ANC \<1.0×10⁹/L or PLT \<100×10⁹/L)
MRD negativity rate
Bone marrow MRD \<0.01% detected by MFC
NGS-MRD negativity rate
NGS-MRD can not detected by IgH/TCR NGS (NGS-based MRD will be incorporated as an exploratory complementary assay in patients with trackable clonotypic rearrangements at diagnosis)
CR1 bridge-to-allo-HSCT rate
Proportion of subjects who achieve CR/CRi and successfully receive allo-HSCT within 2-3 cycles
Overall Survival (OS)
Time from C1D1 to death from any cause; data censored at last follow-up for surviving subjects
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