Mitoxantrone Hydrochloride Liposome, Cytarabine, G-CSF Plus Venetoclax vs. Azacitidine Plus Venetoclax for MDS-IB2 and Secondary/Elderly AML

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital

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

168 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Ruijin Hospital

Lead sponsor

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Collaborator