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NOT YET RECRUITING
NCT07735117
PHASE3

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2026-07-30

Completion Date

2029-07-31

Last Updated

2026-07-29

Healthy Volunteers

No

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.