About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Mitoxantrone Hydrochloride Liposome
- Cytarabine
- Granulocyte Colony-Stimulating Factor(G-CSF)
- Venetoclax
- Venetoclax
- azacitidine
Treatment groups
Locations
Sponsors and collaborators
Ruijin Hospital
Lead sponsor
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Collaborator