Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT06328179

Clinical Study Protocol for the Treatment of ND-AML and RR-AML With KMT2A Gene Abnormalities Using VHEA.

Led by Huai'an First People's Hospital · Updated on 2024-03-25

34

Participants Needed

1

Research Sites

292 weeks

Total Duration

On this page

Sponsors

H

Huai'an First People's Hospital

Lead Sponsor

Z

Zhenjiang First People's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is a clinical trial aimed at evaluating the efficacy and safety of the VHEA(Venetoclax with Homoharringtonine,Etoposide,Cytarabine)regimen in the treatment of newly diagnosed and relapsed/refractory acute myeloid leukemia (AML) with MLL gene abnormalities. This study includes the induction and consolidation phases of AML treatment.

CONDITIONS

Official Title

Clinical Study Protocol for the Treatment of ND-AML and RR-AML With KMT2A Gene Abnormalities Using VHEA.

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 60 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Expected survival time of at least 3 months
  • No severe heart, lung, liver, or kidney disease as defined by specified clinical measures
  • No significant contraindications to chemotherapy as determined by the physician
  • Ability to understand and willingness to sign informed consent form
Not Eligible

You will not qualify if you...

  • Presence of other malignancies
  • Cardiac vascular intervention or stent placement within 12 months, or history of significant cardiac disease such as myocardial infarction or unstable angina
  • Uncontrolled active infection or visceral bleeding
  • Pregnancy or lactation
  • Participation in any other clinical study within 3 months prior to informed consent
  • Any other condition considered unsuitable for participation by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University(Huai'an First People's Hospital)

Huai'an, Jiangsu, China, 210000

Actively Recruiting

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Research Team

S

Shandong Tao

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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