A Phase 2 Study of Bcl-2 Inhibitor Combined With Azacitidine for Newly Diagnosed Mixed Phenotype Acute Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BCL-2 indibitor, Azacitidine (AZA), Blinatumomab.
- Who it may be relevant to
- Registry conditions: Newly Diagnosed Mixed Phenotype Acute Leukemia. Basic parameters: 16 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- Drug BCL-2 indibitor
Sonrotoclax:40mg qd (D1), 80mg qd (D2), 160mg qd (D3), 320mg qd (D4-D21), oral; * 2 cycles. - Drug Azacitidine (AZA)
75mg/m² qd (D1-D7), subcutaneous injection; 28-day cycle, ≥2 cycles - Drug Blinatumomab
9μg/day (D8-D14), 28μg/day (D15-D21), continuous intravenous infusion
Primary outcome measures
- 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）]
Secondary outcome measures (8)
- MRD negativity rate [Time frame: 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]
- CR1 bridge-to-allo-HSCT rate [Time frame: Up to 6 months after enrollment]
- Overall Survival (OS) [Time frame: 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]
- Relapse-Free Survival (RFS) [Time frame: 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]
- Incidence of grade ≥3 adverse events (AEs) [Time frame: From treatment initiation to the end of Induction]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Soochow University — Suzhou
Identifiers
NCT: NCT07573670 · MPAL-1