Acute Myeloid Leukemia (AML)Phase 3NCT07735117
Mitoxantrone Hydrochloride Liposome, Cytarabine, G-CSF Plus Venetoclax vs. Azacitidine Plus Venetoclax for MDS-IB2 and Secondary/Elderly AML
A Phase 3 study testing Mitoxantrone Hydrochloride Liposome, Cytarabine and Granulocyte Colony-Stimulating Factor(G-CSF) in people with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS), run by Ruijin Hospital.
Trial summary
This study aims to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome, subcutaneous cytarabine and G-CSF combined with venetoclax (CMG+Ven) versus azacitidine combined with venetoclax (VA) in the treatment of adult myelodysplastic syndrome IB2 (MDS-IB2) and newly diagnosed secondary or elderly AML. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS)
- What is being tested?
- Mitoxantrone Hydrochloride Liposome, Cytarabine and Granulocyte Colony-Stimulating Factor(G-CSF)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2026to 31 Jul 2029
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. The patient fully understands the study, voluntarily participates, and signs the Informed Consent Form (ICF).
- 2. Age: 18-75 years inclusive. 3. Patients with clinically confirmed adult AML or MDS-IB2 (according to WHO 2022 criteria or ICC 2022 criteria). AML patients must meet any of the following:
- Therapy-related AML
- Prior history of MDS
- Presence of MDS-related genetic/chromosomal abnormalities
- Prior history of CMML
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- Age ≥ 60 years
- Prior history of antecedent MPN (including ET, PV, and MF) with bone marrow fibrosis ≤ grade 2 (on a 0-3 grade scale) 4. For elderly AML patients, comprehensive assessment must show they belong to the Fit population: ECOG < 3, CCI ≤ 0, and MMSE and SPPB assessment results meeting the Fit population criteria.
- 5. Liver and kidney function: ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver infiltration); total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with liver infiltration); serum creatinine ≤ 1.5 × ULN.
- 6. Expected survival ≥ 3 months. 7. Prior MDS-related therapy (excluding blood transfusions) must be completed at least 2 weeks before the start of study treatment. In cases of rapidly proliferative disease, hydroxyurea is permitted up to 24 hours before the start of study treatment. Toxicities from prior MDS therapy must have recovered to Grade 2 or lower before the start of study treatment.
Who cannot join
- Patients who meet any of the following criteria will be excluded from the study:
- Prior anti-cancer treatment history meeting any of the following:
- Prior treatment with mitoxantrone or mitoxantrone liposome.
- Prior treatment with venetoclax or hypomethylating agents.
- Prior treatment with doxorubicin or other anthracyclines, with a cumulative doxorubicin dose > 360 mg/m^2 (for other anthracyclines, 1 mg doxorubicin is equivalent to 2 mg daunorubicin or 0.5 mg idarubicin).
- Received anti-cancer treatment including surgery, chemotherapy, targeted therapy, etc., or participated in another clinical trial with investigational drug within 4 weeks or 5 half-lives before the first dose of study drug.
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- Cardiac function or disease meeting any of the following:
- Long QTc syndrome or QTc interval > 480 ms.
- Complete left bundle branch block, second-degree or third-degree atrioventricular block.
- Severe, uncontrolled arrhythmia requiring medication.
- New York Heart Association (NYHA) Class ≥ II.
- Left ventricular ejection fraction (LVEF) < 50%.
- History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinically significant pericardial disease within 6 months before enrollment, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Concurrent uncontrolled malignancy other than adequately controlled non-melanoma skin basal cell carcinoma, carcinoma in situ of breast/cervix, or other malignancies that have been effectively controlled without treatment for > 6 months and patients receiving long-term non-chemotherapy treatment (e.g., hormone therapy).
- Uncontrolled systemic disease (e.g., progressive infection, uncontrolled hypertension, diabetes mellitus).
- Central nervous system (CNS) leukemia.
- Secondary AML with bone marrow fibrosis ≥ grade 3.
- Blast crisis of chronic myeloid leukemia (CML).
- AML with favorable-risk karyotypes: t(8;21)(q22;q22.1) RUNX1::RUNX1T1, inv(16)(p13.1q22) CBFB::MYH11, or acute promyelocytic leukemia (APL).
- Human immunodeficiency virus (HIV) infection (HIV antibody positive).
- Active hepatitis B or hepatitis C infection (HBsAg or HBcAb positive with HBV-DNA > 1×10^3 copies/mL; HCV antibody positive with HCV-RNA > 1×10^3 copies/mL).
- Known immediate or delayed hypersensitivity reaction to the study drug's class or excipients.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Study of Mitoxantrone Hydrochloride Liposome, Subcutaneous Cytarabine and G-CSF Combined With Venetoclax Versus Azacitidine Combined With Venetoclax in the Treatment of MDS-IB2 and Newly Diagnosed Adult Secondary or Elderly AML
This study aims to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome, subcutaneous cytarabine and G-CSF combined with venetoclax (CMG+Ven) versus azacitidine combined with venetoclax (VA) in the treatment of adult myelodysplastic syndrome IB2 (MDS-IB2) and newly diagnosed secondary or elderly AML.
Read the detailed description
Patients with secondary AML (S-AML) and elderly AML have an extremely poor prognosis due to advanced age, multiple comorbidities, and unfavorable cytogenetic abnormalities. Traditional intensive chemotherapy is associated with low remission rates and substantial toxicity. Myelodysplastic syndrome with excess blasts-2 (MDS-IB2) carries a very high risk of transformation to AML, and its management is similar to that of AML. Although venetoclax, a BCL-2 targeted agent, combined with azacitidine (VA regimen) has revolutionized the treatment paradigm for AML patients unfit for intensive chemotherapy, the VA regimen provides insufficient depth of remission in patients eligible for chemotherapy and is difficult to administer at full dosage and full course, highlighting an urgent need for optimization.
Mitoxantrone hydrochloride liposome is an improved formulation of conventional mitoxantrone. Through liposomal encapsulation and polyethylene glycol modification, it exhibits a prolonged half-life and enhanced tumor targeting, while significantly reducing cardiac toxicity and other non-hematologic toxicities. Our center's previous exploratory study demonstrated that mitoxantrone hydrochloride liposome combined with cytarabine, G-CSF, and venetoclax (CMG+Ven) achieved a composite complete remission (CRc) rate of 72.6% and an MRD-negative rate of 75.6% in patients with newly diagnosed secondary or elderly AML. Furthermore, compared with the VA regimen, CMG+Ven significantly increased the MRD-negative rate and shortened hospital stay, showing promising clinical potential.
Therefore, the investigators designed a prospective, multicenter, randomized controlled trial. The study plans to enroll 168 adult patients with clinically confirmed MDS-IB2 and newly diagnosed secondary or elderly AML. Participants will be randomly assigned in a 1:1 ratio to receive one of the following induction treatments: 1) mitoxantrone hydrochloride liposome, subcutaneous cytarabine, and G-CSF combined with venetoclax (CMG+VEN), or 2) azacitidine combined with venetoclax (VA). The primary endpoint is the composite complete remission (CRc) rate following induction therapy.
- Being tested
- Mitoxantrone Hydrochloride Liposome, Cytarabine, Granulocyte Colony-Stimulating Factor(G-CSF), Venetoclax, azacitidine
- Keywords
- Acute myeloid leukemia, Myelodysplastic Syndromes, mitoxantrone hydrochloride liposome, Cytarabine, Granulocyte Colony-Stimulating Factor, Venetoclax, Randomized Controlled Trial
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone Hydrochloride LiposomeDrug
Mitoxantrone Hydrochloride Liposome: 15 mg/m², administered by intravenous drip (ivgtt) on day 1
CytarabineDrug
Cytarabine: 10 mg/m², administered subcutaneously (H) every 12 hours (q12h) on days 1-7
Granulocyte Colony-Stimulating Factor(G-CSF)Drug
G-CSF: 5 μg/kg, administered subcutaneously (H) starting from day 0, and discontinued when WBC ≥ 20×10^9/L
VenetoclaxDrug
Venetoclax: 100 mg on day 2, 200 mg on day 3, and 400 mg on days 4-10, administered orally (po)
VenetoclaxDrug
Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-21 or 3-28, administered orally (po)
azacitidineDrug
Azacitidine: 75 mg/m^2, administered subcutaneously (H) on days 1-7.
| Study group | Role | What they receive |
|---|---|---|
| CMG+VEN | Experimental | Patients who achieve complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi), or morphologic leukemia-free state (MLFS) following Cycle 1 will proceed to consolidation therapy.
Patients achieving a partial response (PR) or a ≥50% reduction in bone marrow blasts after Cycle 1 will receive one additional cycle of re-induction therapy with the same CMG+Ven regimen (venetoclax 400 mg daily on Days 1-7).
Those who subsequently attain CR, CRh, CRi, or MLFS after Cycle 2 will proceed to consolidation therapy.
Patients with no response (NR) after Cycle 1, or with NR or PR after Cycle 2, will discontinue study treatment. Receives: Drug: Mitoxantrone Hydrochloride Liposome; Drug: Cytarabine; Drug: Granulocyte Colony-Stimulating Factor(G-CSF); Drug: Venetoclax |
| VA | Active comparator | Patients who achieve complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi), or morphologic leukemia-free state (MLFS) following Cycle 1 will proceed to consolidation therapy.
Patients achieving a partial response (PR) or a ≥50% reduction in bone marrow blasts after Cycle 1 will receive one additional cycle of re-induction therapy with the same VA regimen.
Those who subsequently attain CR, CRh, CRi, or MLFS after Cycle 2 will proceed to consolidation therapy.
Patients with no response (NR) after Cycle 1, or with NR or PR after Cycle 2, will discontinue study treatment. Receives: Drug: Venetoclax; Drug: azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Composite Complete Remission (CRc = CR + CRh + CRI) in Induction Therapy (Assessed via European LeukemiaNet [ELN] 2022 Criteria)
Number of participants achieving composite complete remission (CRc), defined as complete remission (CR) + complete remission with partial hematologic recovery (CRh) + complete remission with incomplete hematologic recovery (CRI), assessed at the end of each 28-day cycle (up to 2 cycles) using European LeukemiaNet [ELN] 2022 criteria.
Measured: At the end of each cycle (each cycle is 28 days), up to 2 cycles
Secondary outcomes (7)
Proportion of Participants With Objective Response (ORR = CRC + Morphologic Leukemia-Free State [MLFS] + Partial Remission [PR]) in Induction Therapy (Assessed via European LeukemiaNet [ELN] 2022 Criteria)
Number of participants achieving objective response (ORR), defined as composite complete remission (CRC) + morphologic leukemia-free state (MLFS) + partial remission (PR), assessed at the end of each 28-day cycle (up to 2 cycles) using European LeukemiaNet [ELN] 2022 criteria.
Measured: At the end of each cycle (each cycle is 28 days), up to 2 cycles
Proportion of CRc-Achieving Participants With Measurable Residual Disease (MRD) Negativity (Assessed via Flow Cytometry Testing Per ELN 2022 Criteria)
Number of participants who achieved CRc and had MRD negativity, assessed at the end of each 28-day cycle (up to 2 cycles) using flow cytometry testing per European LeukemiaNet [ELN] 2022 criteria.
Measured: At the end of each cycle (each cycle is 28 days), up to 2 cycles
Overall Survival (OS) Time (From Treatment Day 1 to Date of Death From Any Cause)
Time from day 1 of treatment to date of death from any cause, measured for all participants in the study, up to 1 year after the last enrolled participant's enrollment date.
Measured: Up to 1 years after the date of the last enrolled participants
Relapsed-Free Survival (RFS) Time (From CRc Achievement to Hematologic Relapse or Death From Any Cause)
Time from date of achieving CRc to date of hematologic relapse or death from any cause, measured only for participants who achieved CRc, up to 1 year after the last enrolled participant's enrollment date.
Measured: Up to 1 years after the date of the last enrolled participants
Event-Free Survival (EFS) Time (From Treatment Day 1 to Treatment Failure, Hematologic Relapse From CRc, or Death From Any Cause [Whichever Occurs First])
Time from day 1 of treatment to date of treatment failure, hematologic relapse from CRc, or death from any cause (whichever occurs first), measured for all participants in the study, up to 1 year after the last enrolled participant's enrollment date.
Measured: Up to 1 years after the date of the last enrolled participants
Incidence of Treatment-Emergent Adverse Events (Assessed via Common Terminology Criteria for Adverse Events [CTCAE] v5.0)
Number of participants with treatment-emergent adverse events, assessed via Common Terminology Criteria for Adverse Events [CTCAE] v5.0, from day 1 of treatment to 28 days after the last dose.
Measured: From day 1 of treatment to 28 days after the last dose
Exploratory Biomarker Profiling (Including Genetic Mutations, Gene Expression Profiles, and Molecular Markers in Blood/Bone Marrow)
Assessment of exploratory biomarkers (including genetic mutations, gene expression profiles, and molecular markers) in blood or bone marrow, to explore association with treatment response/resistance/prognosis in AML, at baseline and end of each 28-day cycle (up to 2 cycles).
Measured: Baseline, end of each cycle (up to 2 cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start30 Jul 2026 (estimated)
- Primary completion20 Jul 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sujiang Zhang, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735117
- Sponsor's protocol ID
- CSPC-DED-AML-K24
- Status last verified
- Apr 2026
- First submitted
- 8 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Clinical Study of Mitoxantrone Hydrochloride Liposome, Subcutaneous Cytarabine and G-CSF Combined With Venetoclax Versus Azacitidine Combined With Venetoclax in the Treatment of MDS-IB2 and Newly Diagnosed Adult Secondary or Elderly AML
- ClinicalTrials.gov ID
- NCT07735117
- Acronym / sponsor ID
- CSPC-DED-AML-K24
- Keywords
- Acute myeloid leukemia, Myelodysplastic Syndromes, mitoxantrone hydrochloride liposome, Cytarabine, Granulocyte Colony-Stimulating Factor, Venetoclax, Randomized Controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 20 Jul 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 29 Jul 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 study aims to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome, subcutaneous cytarabine and G-CSF combined with venetoclax (CMG+Ven) versus azacitidine combined with venetoclax (VA) in the treatment of adult myelodysplastic syndrome IB2 (MDS-IB2) and newly diagnosed secondary or elderly AML.
Detailed description
Patients with secondary AML (S-AML) and elderly AML have an extremely poor prognosis due to advanced age, multiple comorbidities, and unfavorable cytogenetic abnormalities. Traditional intensive chemotherapy is associated with low remission rates and substantial toxicity. Myelodysplastic syndrome with excess blasts-2 (MDS-IB2) carries a very high risk of transformation to AML, and its management is similar to that of AML. Although venetoclax, a BCL-2 targeted agent, combined with azacitidine (VA regimen) has revolutionized the treatment paradigm for AML patients unfit for intensive chemotherapy, the VA regimen provides insufficient depth of remission in patients eligible for chemotherapy and is difficult to administer at full dosage and full course, highlighting an urgent need for optimization.
Mitoxantrone hydrochloride liposome is an improved formulation of conventional mitoxantrone. Through liposomal encapsulation and polyethylene glycol modification, it exhibits a prolonged half-life and enhanced tumor targeting, while significantly reducing cardiac toxicity and other non-hematologic toxicities. Our center's previous exploratory study demonstrated that mitoxantrone hydrochloride liposome combined with cytarabine, G-CSF, and venetoclax (CMG+Ven) achieved a composite complete remission (CRc) rate of 72.6% and an MRD-negative rate of 75.6% in patients with newly diagnosed secondary or elderly AML. Furthermore, compared with the VA regimen, CMG+Ven significantly increased the MRD-negative rate and shortened hospital stay, showing promising clinical potential.
Therefore, the investigators designed a prospective, multicenter, randomized controlled trial. The study plans to enroll 168 adult patients with clinically confirmed MDS-IB2 and newly diagnosed secondary or elderly AML. Participants will be randomly assigned in a 1:1 ratio to receive one of the following induction treatments: 1) mitoxantrone hydrochloride liposome, subcutaneous cytarabine, and G-CSF combined with venetoclax (CMG+VEN), or 2) azacitidine combined with venetoclax (VA). The primary endpoint is the composite complete remission (CRc) rate following induction therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMG+VEN | Experimental | Drug: Mitoxantrone Hydrochloride Liposome, Drug: Cytarabine, Drug: Granulocyte Colony-Stimulating Factor(G-CSF), Drug: VenetoclaxPatients who achieve complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi), or morphologic leukemia-free state (MLFS) following Cycle 1 will proceed to consolidation therapy. Patients achieving a partial response (PR) or a ≥50% reduction in bone marrow blasts after Cycle 1 will receive one additional cycle of re-induction therapy with the same CMG+Ven regimen (venetoclax 400 mg daily on Days 1-7). Those who subsequently attain CR, CRh, CRi, or MLFS after Cycle 2 will proceed to consolidation therapy. Patients with no response (NR) after Cycle 1, or with NR or PR after Cycle 2, will discontinue study treatment. |
| VA | Active comparator | Drug: Venetoclax, Drug: azacitidinePatients who achieve complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi), or morphologic leukemia-free state (MLFS) following Cycle 1 will proceed to consolidation therapy. Patients achieving a partial response (PR) or a ≥50% reduction in bone marrow blasts after Cycle 1 will receive one additional cycle of re-induction therapy with the same VA regimen. Those who subsequently attain CR, CRh, CRi, or MLFS after Cycle 2 will proceed to consolidation therapy. Patients with no response (NR) after Cycle 1, or with NR or PR after Cycle 2, will discontinue study treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. The patient fully understands the study, voluntarily participates, and signs the Informed Consent Form (ICF).
- 2. Age: 18-75 years inclusive. 3. Patients with clinically confirmed adult AML or MDS-IB2 (according to WHO 2022 criteria or ICC 2022 criteria). AML patients must meet any of the following:
- 5. Liver and kidney function: ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver infiltration); total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with liver infiltration); serum creatinine ≤ 1.5 × ULN.
- 6. Expected survival ≥ 3 months. 7. Prior MDS-related therapy (excluding blood transfusions) must be completed at least 2 weeks before the start of study treatment. In cases of rapidly proliferative disease, hydroxyurea is permitted up to 24 hours before the start of study treatment. Toxicities from prior MDS therapy must have recovered to Grade 2 or lower before the start of study treatment.
Key exclusion criteria (22 listed)
- Patients who meet any of the following criteria will be excluded from the study:
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 |
|---|---|---|
| Mitoxantrone Hydrochloride LiposomeMitoxantrone Hydrochloride Liposome: 15 mg/m², administered by intravenous drip (ivgtt) on day 1 | Drug | CMG+VEN |
| CytarabineCytarabine: 10 mg/m², administered subcutaneously (H) every 12 hours (q12h) on days 1-7 | Drug | CMG+VEN |
| Granulocyte Colony-Stimulating Factor(G-CSF)G-CSF: 5 μg/kg, administered subcutaneously (H) starting from day 0, and discontinued when WBC ≥ 20×10^9/L | Drug | CMG+VEN |
| VenetoclaxVenetoclax: 100 mg on day 2, 200 mg on day 3, and 400 mg on days 4-10, administered orally (po) | Drug | CMG+VEN |
| VenetoclaxVenetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-21 or 3-28, administered orally (po) | Drug | VA |
| azacitidineAzacitidine: 75 mg/m^2, administered subcutaneously (H) on days 1-7. | Drug | VA |
Primary outcome
Proportion of Participants With Composite Complete Remission (CRc = CR + CRh + CRI) in Induction Therapy (Assessed via European LeukemiaNet [ELN] 2022 Criteria)
Time frame: At the end of each cycle (each cycle is 28 days), up to 2 cycles
Number of participants achieving composite complete remission (CRc), defined as complete remission (CR) + complete remission with partial hematologic recovery (CRh) + complete remission with incomplete hematologic recovery (CRI), assessed at the end of each 28-day cycle (up to 2 cycles) using European LeukemiaNet [ELN] 2022 criteria.
7 secondary outcomes
Proportion of Participants With Objective Response (ORR = CRC + Morphologic Leukemia-Free State [MLFS] + Partial Remission [PR]) in Induction Therapy (Assessed via European LeukemiaNet [ELN] 2022 Criteria)
Time frame: At the end of each cycle (each cycle is 28 days), up to 2 cycles
Proportion of CRc-Achieving Participants With Measurable Residual Disease (MRD) Negativity (Assessed via Flow Cytometry Testing Per ELN 2022 Criteria)
Time frame: At the end of each cycle (each cycle is 28 days), up to 2 cycles
Overall Survival (OS) Time (From Treatment Day 1 to Date of Death From Any Cause)
Time frame: Up to 1 years after the date of the last enrolled participants
Relapsed-Free Survival (RFS) Time (From CRc Achievement to Hematologic Relapse or Death From Any Cause)
Time frame: Up to 1 years after the date of the last enrolled participants
Event-Free Survival (EFS) Time (From Treatment Day 1 to Treatment Failure, Hematologic Relapse From CRc, or Death From Any Cause [Whichever Occurs First])
Time frame: Up to 1 years after the date of the last enrolled participants
Incidence of Treatment-Emergent Adverse Events (Assessed via Common Terminology Criteria for Adverse Events [CTCAE] v5.0)
Time frame: From day 1 of treatment to 28 days after the last dose
Exploratory Biomarker Profiling (Including Genetic Mutations, Gene Expression Profiles, and Molecular Markers in Blood/Bone Marrow)
Time frame: Baseline, end of each cycle (up to 2 cycles)
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 29 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Sujiang Zhang principal investigator
Ruijin Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mitoxantrone Hydrochloride Liposome, Cytarabine and Granulocyte Colony-Stimulating Factor(G-CSF) in people with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS), run by Ruijin Hospital.
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 10 inclusion and 22 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 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xiaoqian Xu (13816205940, Ellenxxq@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Composite Complete Remission (CRc = CR + CRh + CRI) in Induction Therapy (Assessed via European LeukemiaNet [ELN] 2022 Criteria) (time frame: At the end of each cycle (each cycle is 28 days), up to 2 cycles). 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 29 Jul 2026.