Actively Recruiting

Phase 2
Age: 60Years - 70Years
All Genders
NCT06621199

Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML

Led by First Affiliated Hospital of Zhejiang University · Updated on 2024-10-01

42

Participants Needed

1

Research Sites

181 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital of Zhejiang University

Lead Sponsor

C

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome in combination with cytarabine and venetoclax (MAV) regimen in newly diagnosed elderly AML. To account, conservatively, for a 10% dropout rate before study completion, we planned to include 42 patients. The primary endpoint is 2-year event free survival(EFS).

CONDITIONS

Official Title

Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML

Who Can Participate

Age: 60Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form indicating understanding and willingness to participate
  • Aged 60 to 70 years, including the ages 60 and 70
  • Newly diagnosed primary acute myeloid leukemia according to WHO 2022 classification
  • Eastern Oncology Collaboration Group (ECOG) physical status score of 0 to 2
  • Life expectancy of at least 3 months
  • Liver enzymes ALT/AST less than or equal to 2.5 times the upper limit of normal (ULN), or less than or equal to 5 times ULN if liver infiltration is present
  • Total bilirubin less than or equal to 1.5 times ULN, or less than or equal to 3 times ULN if liver infiltration is present
  • Serum creatinine less than or equal to 1.5 times ULN
Not Eligible

You will not qualify if you...

  • Diagnosis of acute promyelocytic leukemia
  • Secondary AML caused by chemotherapy or radiotherapy for solid tumors or prior blood disorders such as MDS, MPN, or MDS/MPN
  • AML following blast transformation of chronic myeloid leukemia
  • Central nervous system leukemia
  • Malignant tumors within the past 5 years, except cured skin basal cell carcinoma, cervical carcinoma in situ, or effectively controlled tumors
  • Prior anthracycline treatment or other anti-AML treatments except hydroxyurea, leukapheresis, or leukocyte-lowering therapies
  • Use of strong or moderate CYP3A inducers/inhibitors or P-glycoprotein inhibitors within 7 days before starting study treatment
  • Inability to take oral medications or presence of malabsorption syndrome
  • Cardiac conditions including long QTc syndrome, complete left bundle branch block, significant arrhythmias, NYHA class II or higher heart failure, ejection fraction below 50%, recent serious heart disease
  • Uncontrolled systemic diseases such as advanced infections, uncontrolled hypertension, or diabetes
  • HIV infection
  • Positive hepatitis B or C markers with significant viral load
  • History of severe allergy to study drugs or their components
  • History of severe neurological or psychiatric illness
  • Any condition deemed unsuitable for the study by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310003

Actively Recruiting

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Research Team

J

Jie Jin, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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