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

May 1, 2026 updated by: Chen Suning, The First Affiliated Hospital of Soochow University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • the First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A: T/Myeloid MPAL

Sonrotoclax: 40mg qd (D1), 80mg qd (D2), 160mg qd (D3), 320mg qd (D4-D21), oral; Azacitidine: 75mg/m² qd (D1-D7), subcutaneous injection; 28-day cycle, ≥2 cycles.

Patients who achieve CRc will undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) following 2 to 3 cycles of consolidation therapy.
Drug: BCL-2 indibitor

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

  • 2 cycles.
Other Names:
  • Sonrotoclax
Drug: Azacitidine (AZA)
75mg/m² qd (D1-D7), subcutaneous injection; 28-day cycle, ≥2 cycles
Other Names:
  • Azacitidine
Experimental: Cohort B: B/Myeloid MPAL

Sonrotoclax: 40mg qd (D1), 80mg qd (D2), 160mg qd (D3), 320mg qd (D4-D21), oral; Azacitidine: 75mg/m² qd (D1-D7), subcutaneous injection; Blinatumomab: 9μg/day (D8-D14), 28μg/day (D15-D21), continuous intravenous infusion; 28-day cycle, ≥2 cycles.

Patients who achieve CRc will undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) following 2 to 3 cycles of consolidation therapy.
Drug: BCL-2 indibitor

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

  • 2 cycles.
Other Names:
  • Sonrotoclax
Drug: Azacitidine (AZA)
75mg/m² qd (D1-D7), subcutaneous injection; 28-day cycle, ≥2 cycles
Other Names:
  • Azacitidine
Drug: Blinatumomab
9μg/day (D8-D14), 28μg/day (D15-D21), continuous intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From randomization to 2 cycles of induction before consolidation therapy（100 days）

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From randomization to 2 cycles of induction before consolidation therapy（100 days）
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)
From randomization to 2 cycles of induction before consolidation therapy（100 days）, and test Every 3 months during follow-up
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
Up to 6 months after enrollment
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
From the time from randomization to time for up to 2 years
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
From the time from randomization to time for up to 2 years
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
From the time from randomization to time for up to 2 years
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
Up to 100 days after initial MPAL diagnosis
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
From treatment initiation to the end of Induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Investigators

  • Principal Investigator: Suning Chen, The First Affiliated Hospital of Soochow University Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

April 26, 2026

First Submitted That Met QC Criteria

May 1, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPAL-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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