A Phase 2 Study of Bcl-2 Inhibitor Combined With Azacitidine for Newly Diagnosed Mixed Phenotype Acute Leukemia

NCT07573670 · tracked via the Priya Life Science China tracker

Sponsor

The First Affiliated Hospital of Soochow University

Phase

Phase 2

Started

2026-05-01

Last updated

2026-05-07

Condition(s) studied

Newly Diagnosed Mixed Phenotype Acute Leukemia

Investigational drug(s) / intervention(s)

BCL-2 indibitorAzacitidine (AZA)Blinatumomab

BCL-2 indibitor: Sonrotoclax:40mg qd (D1), 80mg qd (D2), 160mg qd (D3), 320mg qd (D4-D21), oral; * 2 cycles.

Azacitidine (AZA): 75mg/m² qd (D1-D7), subcutaneous injection; 28-day cycle, ≥2 cycles

Blinatumomab: 9μg/day (D8-D14), 28μg/day (D15-D21), continuous intravenous infusion

Study summary

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.

Eligibility

Sex

ALL

Min age

16 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: 1. Aged 16 to 70 years old 2. Newly diagnosed MPAL confirmed by the 2022 WHO/ICC classification criteria for hematopoietic and lymphoid neoplasms 3. Previously untreated; use of glucocorticoids or hydroxyurea for ≤7 days to control tumor burden before enrollment is allowed, no other systemic anti-leukemia therapy 4. ECOG performance status score 0-3 5. No severe combined heart, brain, lung, liver or kidney disease, judged by the investigator to tolerate the study regimen 6. Able to understand and voluntarily sign a written informed consent form Exclusion Criteria: 1. BCR::ABL-positive MPAL patients 2. Presence of active, uncontrolled infection 3. Known uncontrolled active central nervous system leukemia (CNSL) 4. Life-threatening extramedullary disease requiring urgent radiotherapy or surgical debulking 5. Severe cardiac insufficiency with left ventricular ejection fraction (LVEF) \<40% 6. Previous receipt of systemic anti-leukemia therapy 7. Pregnant or lactating female subjects 8. Judged by the investigator to be ineligible for the study for other reasons

Primary outcome measure(s)

Composite Complete Response (CRc) rate after 2 cycles of induction therapy — From randomization to 2 cycles of induction before consolidation therapy（100 days）
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)

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07573670 on ClinicalTrials.gov ↗ ← All trials in China