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NCT Number: NCT07573670

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

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.

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Key information

Conditions

Newly Diagnosed Mixed Phenotype Acute Leukemia

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • No severe combined heart, brain, lung, liver or kidney disease, judged by the investigator to tolerate the study regimen
  • Able to understand and voluntarily sign a written informed consent form

Exclusion criteria

  • 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
  • Severe cardiac insufficiency with left ventricular ejection fraction (LVEF) <40%
  • Previous receipt of systemic anti-leukemia therapy
  • Pregnant or lactating female subjects
  • Judged by the investigator to be ineligible for the study for other reasons

Treatment and study plan

BCL-2 indibitor

Drug

Sonrotoclax:40mg qd (D1), 80mg qd (D2), 160mg qd (D3), 320mg qd (D4-D21), oral;

  • 2 cycles.

Other names: Sonrotoclax

Azacitidine (AZA)

Drug

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

Other names: Azacitidine

Blinatumomab

Drug

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

Primary outcomes

  1. Composite Complete Response (CRc) rate after 2 cycles of induction therapy

    Time frame: 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)

Secondary outcomes

  1. MRD negativity rate

    Time frame: From randomization to 2 cycles of induction before consolidation therapy（100 days）

    Bone marrow MRD <0.01% detected by MFC

  2. NGS-MRD negativity rate

    Time frame: From randomization to 2 cycles of induction before consolidation therapy（100 days）, and test Every 3 months during follow-up

    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)

  3. CR1 bridge-to-allo-HSCT rate

    Time frame: Up to 6 months after enrollment

    Proportion of subjects who achieve CR/CRi and successfully receive allo-HSCT within 2-3 cycles

  4. Overall Survival (OS)

    Time frame: From the time from randomization to time for up to 2 years

    Time from C1D1 to death from any cause; data censored at last follow-up for surviving subjects

  5. Event-Free Survival (EFS)

    Time frame: From the time from randomization to time for up to 2 years

    Time from C1D1 to first event (no CRc after 2 cycles, morphological/extramedullary relapse, disease progression, off-protocol anti-leukemia therapy, death from any cause); data censored at last follow-up for event-free subjects

  6. Relapse-Free Survival (RFS)

    Time frame: From the time from randomization to time for up to 2 years

    Time from first CR/CRi to relapse or death from any cause; relapse defined as bone marrow blasts ≥5%, extramedullary disease, peripheral blasts, or molecular MRD ≥10-⁴ in previously MRD-negative patients;data censored at last follow-up for relapse-free subjects

  7. 100-day Non-Relapse Mortality (100-day NRM)

    Time frame: Up to 100 days after initial MPAL diagnosis

    Proportion of deaths from non-relapse causes within 100 days of diagnosis

  8. Incidence of grade ≥3 adverse events (AEs)

    Time frame: From treatment initiation to the end of Induction

    Type, frequency and severity of grade ≥3 AEs graded by CTCAE v5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Lu Doctor

CONTACT

[email protected]

86+0512-67781137

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Registry information

Official study title

A Prospective, Open-Label, Single-Arm, Two-Cohort Phase 2 Clinical Study to Evaluate the Efficacy and Safety of Bcl-2 Inhibitor Combined With Azacitidine in the Treatment of Newly Diagnosed Mixed Phenotype Acute Leukemia

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.