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

NCT07735117 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2026-07-29

No results posted yet for this study

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.

Conditions

  • Acute Myeloid Leukemia (AML)
  • Myelodysplastic Syndromes (MDS)

Interventions

DRUG

Mitoxantrone Hydrochloride Liposome

Mitoxantrone Hydrochloride Liposome: 15 mg/m², administered by intravenous drip (ivgtt) on day 1

DRUG

Cytarabine

Cytarabine: 10 mg/m², administered subcutaneously (H) every 12 hours (q12h) on days 1-7

DRUG

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

Venetoclax

Venetoclax: 100 mg on day 2, 200 mg on day 3, and 400 mg on days 4-10, administered orally (po)

DRUG

Venetoclax

Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-21 or 3-28, administered orally (po)

DRUG

azacitidine

Azacitidine: 75 mg/m\^2, administered subcutaneously (H) on days 1-7.

Sponsors & Collaborators

  • CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

    collaborator INDUSTRY

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Sujiang Zhang · Ruijin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-30
Primary Completion
2028-07-20
Completion
2029-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07735117 on ClinicalTrials.gov