Actively Recruiting

Phase Not Applicable
Age: 60Years - 85Years
All Genders
NCT05909293

Clinical Study Protocol of Maintenance Therapy With Venetoclax in Elderly Patients With AML in First Complete Remission

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-06-18

100

Participants Needed

1

Research Sites

267 weeks

Total Duration

On this page

Sponsors

T

The First Affiliated Hospital with Nanjing Medical University

Lead Sponsor

H

Huai'an First People's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This clinical study evaluates the efficacy and safety of maintenance therapy with BCL-2 inhibitors in elderly patients with acute myeloid leukemia (AML) in first complete remission. This study involves the following content: BCL-2 inhibitors.

CONDITIONS

Official Title

Clinical Study Protocol of Maintenance Therapy With Venetoclax in Elderly Patients With AML in First Complete Remission

Who Can Participate

Age: 60Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of acute myeloid leukemia (AML) based on bone marrow and immunophenotyping per WHO 2016 criteria
  • Achieved first complete remission (CR) or incomplete remission (CRi) after 1-2 induction therapy cycles
  • Completed at least 4 cycles of consolidation therapy
  • Age between 60 and 85 years
  • Liver function tests (AST, ALT, ALP) no more than 3 times the upper limit of normal
  • Serum bilirubin no more than 1.5 times the upper limit of normal
  • Serum creatinine no more than 2.0 times the upper limit of normal
  • Serum creatine kinase less than 2.0 times the upper limit of normal
  • Left ventricular ejection fraction (LVEF) of 50% or higher
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 3
  • Provided informed consent by patient or legal representative
Not Eligible

You will not qualify if you...

  • Acute promyelocytic leukemia, myeloid sarcoma, or blast phase of chronic myeloid leukemia
  • Achieved remission only after relapse and re-induction therapy
  • Extramedullary AML involvement, including active central nervous system leukemia
  • Allergy to any drugs used in this study protocol
  • Pregnant or breastfeeding women, or those unwilling to use contraception if of reproductive age
  • Significant liver or kidney function abnormalities exceeding inclusion limits
  • Organic heart disease such as uncontrolled arrhythmias, symptomatic heart failure, or recent myocardial infarction within 6 months
  • Other active malignant tumors except for certain treated cancers without active disease as specified
  • Infection with HIV/AIDS, syphilis, active hepatitis B or C
  • Any other medical conditions or infections that may interfere with study participation or safety
  • Inability to understand or follow the study protocol
  • Undergoing major surgery within 4 weeks prior to randomization
  • Prior allogeneic hematopoietic stem cell transplantation

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 with Nanjing Medical University

Nanjing, Jiangsu, China, 210000

Actively Recruiting

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Research Team

M

Ming Hong, MD

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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