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.
1. The patient fully understands the study, voluntarily participates, and signs the Informed Consent Form (ICF).
Therapy-related AML
Prior history of MDS
Presence of MDS-related genetic/chromosomal abnormalities
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/m² (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.
Parallel
Mitoxantrone Hydrochloride Liposome
DrugMitoxantrone Hydrochloride Liposome: 15 mg/m², administered by intravenous drip (ivgtt) on day 1
Cytarabine
DrugCytarabine: 10 mg/m², administered subcutaneously (H) every 12 hours (q12h) on days 1-7
Granulocyte Colony-Stimulating Factor(G-CSF)
DrugG-CSF: 5 μg/kg, administered subcutaneously (H) starting from day 0, and discontinued when WBC ≥ 20×10\^9/L
Venetoclax
DrugVenetoclax: 100 mg on day 2, 200 mg on day 3, and 400 mg on days 4-10, administered orally (po)
Venetoclax
DrugVenetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-21 or 3-28, administered orally (po)
azacitidine
DrugAzacitidine: 75 mg/m\^2, administered subcutaneously (H) on days 1-7.
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.
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.
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.
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.
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.
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Ruijin Hospital
Lead sponsor
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
