Newly Diagnosed Mixed Phenotype Acute LeukemiaPhase 2NCT07573670
A Phase 2 Study of Bcl-2 Inhibitor Combined With Azacitidine for Newly Diagnosed Mixed Phenotype Acute Leukemia
A Phase 2 study testing BCL-2 indibitor, Azacitidine (AZA) and Blinatumomab in people with Newly Diagnosed Mixed Phenotype Acute Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Newly Diagnosed Mixed Phenotype Acute Leukemia
- What is being tested?
- BCL-2 indibitor, Azacitidine (AZA) and Blinatumomab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
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
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.
- Being tested
- BCL-2 indibitor, Azacitidine (AZA), Blinatumomab
- Keywords
- Newly diagnosed Mixed Phenotype Acute Leukemia, Bcl-2 inhibitor (Sonrotoclax)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCL-2 indibitorDrug
Also called Sonrotoclax
Sonrotoclax:40mg qd (D1), 80mg qd (D2), 160mg qd (D3), 320mg qd (D4-D21), oral;
- 2 cycles.
Azacitidine (AZA)Drug
Also called Azacitidine
75mg/m² qd (D1-D7), subcutaneous injection; 28-day cycle, ≥2 cycles
BlinatumomabDrug
9μg/day (D8-D14), 28μg/day (D15-D21), continuous intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: T/Myeloid MPAL | Experimental | 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. Receives: Drug: BCL-2 indibitor; Drug: Azacitidine (AZA) |
| Cohort B: B/Myeloid MPAL | Experimental | 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. Receives: Drug: BCL-2 indibitor; Drug: Azacitidine (AZA); Drug: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From randomization to 2 cycles of induction before consolidation therapy（100 days）
Secondary outcomes (8)
MRD negativity rate
Bone marrow MRD <0.01% detected by MFC
Measured: From randomization to 2 cycles of induction before consolidation therapy（100 days）
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)
Measured: 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
Proportion of subjects who achieve CR/CRi and successfully receive allo-HSCT within 2-3 cycles
Measured: Up to 6 months after enrollment
Overall Survival (OS)
Time from C1D1 to death from any cause; data censored at last follow-up for surviving subjects
Measured: From the time from randomization to time for up to 2 years
Event-Free Survival (EFS)
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
Measured: From the time from randomization to time for up to 2 years
Relapse-Free Survival (RFS)
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
Measured: From the time from randomization to time for up to 2 years
100-day Non-Relapse Mortality (100-day NRM)
Proportion of deaths from non-relapse causes within 100 days of diagnosis
Measured: Up to 100 days after initial MPAL diagnosis
Incidence of grade ≥3 adverse events (AEs)
Type, frequency and severity of grade ≥3 AEs graded by CTCAE v5.0
Measured: From treatment initiation to the end of Induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Mixed Phenotype Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two independent cohorts based on immunophenotype： Cohort A (T/Myeloid MPAL) Cohort B (B/Myeloid MPAL)
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Suning, The First Affiliated Hospital of Soochow University
- Investigators
- Suning Chen, Principal investigator, The First Affiliated Hospital of Soochow University Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573670
- Sponsor's protocol ID
- MPAL-1
- Status last verified
- May 2026
- First submitted
- 26 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07573670
- Acronym / sponsor ID
- MPAL-1
- Keywords
- Newly diagnosed Mixed Phenotype Acute Leukemia, Bcl-2 inhibitor (Sonrotoclax)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two independent cohorts based on immunophenotype： Cohort A (T/Myeloid MPAL) Cohort B (B/Myeloid MPAL)
| Arm | Type | Receives |
|---|---|---|
| Cohort A: T/Myeloid MPAL | Experimental | Drug: BCL-2 indibitor, Drug: Azacitidine (AZA)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. |
| Cohort B: B/Myeloid MPAL | Experimental | Drug: BCL-2 indibitor, Drug: Azacitidine (AZA), Drug: BlinatumomabSonrotoclax: 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. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCL-2 indibitorAlso: SonrotoclaxSonrotoclax:40mg qd (D1), 80mg qd (D2), 160mg qd (D3), 320mg qd (D4-D21), oral; * 2 cycles. | Drug | Cohort A: T/Myeloid MPAL, Cohort B: B/Myeloid MPAL |
| Azacitidine (AZA)Also: Azacitidine75mg/m² qd (D1-D7), subcutaneous injection; 28-day cycle, ≥2 cycles | Drug | Cohort A: T/Myeloid MPAL, Cohort B: B/Myeloid MPAL |
| Blinatumomab9μg/day (D8-D14), 28μg/day (D15-D21), continuous intravenous infusion | Drug | Cohort B: B/Myeloid MPAL |
Primary outcome
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)
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suning Chen principal investigator
The First Affiliated Hospital of Soochow University Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BCL-2 indibitor, Azacitidine (AZA) and Blinatumomab in people with Newly Diagnosed Mixed Phenotype Acute Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Lu Doctor (86+0512-67781137, gloriajlu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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）). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.