Comparing standard-dose and intermediate-dose cytarabine for treating acute myeloid leukemia with RUNX1-RUNX1T1 fusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III clinical trial aims to evaluate the effectiveness of standard-dose versus intermediate-dose cytarabine induction therapy in adult patients with acute myeloid leukemia (AML) who express the RUNX1-RUNX1T1 fusion gene. Eligible participants will be randomly assigned to receive either standard or intermediate doses of daunorubicin and cytarabine. The study will assess the rates of complete remission after induction therapy and the subsequent need for consolidation therapy. Patients who do not achieve remission after two cycles will be withdrawn from the treatment protocol. The trial seeks to determine if the intermediate-dose regimen can improve outcomes without increasing treatment-related mortality.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. AML conforming to WHO (2022) or ICC standards
2. Possessing the RUNX1::RUNX1T1 fusion gene
3. Age ranging from 14 to 60 years old, regardless of gender.
4. The performance status assessment of the Eastern Cooperative Oncology Group (ECOG-PS) being 0 - 2.
5. Meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment):

1\) Total bilirubin ≤ 1.5 times the upper limit of the normal value for the same age group; 2) AST and ALT ≤ 2.5 times the upper limit of the normal value for the same age group; 3) Serum creatinine \< 2 times the upper limit of the normal value for the same age group; 4) Cardiac enzymes \< 2 times the upper limit of the normal value for the same age group; 5) The cardiac ejection fraction determined by echocardiography (ECHO) \> 50%. An informed consent form must be signed before the commencement of all specific research procedures, either by the patient themselves or their immediate relatives. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the informed consent form shall be signed by the legal guardian or the immediate relatives of the patient.

Exclusion Criteria:

1. Acute promyelocytic leukemia accompanied by PML-RARA fusion gene.
2. Acute myeloid leukemia featuring BCR-ABL fusion gene.
3. Patients undergoing retreatment (but can receive cytoreductive therapy with hydroxyurea and cytarabine).
4. Individuals concurrently having malignant tumors in other organs (requiring treatment).
5. Active cardiac disorders, defined as one or more of the following:

1\) A history of uncontrolled or symptomatic angina pectoris; 2) Myocardial infarction less than 6 months from study enrollment; 3) A history of significant arrhythmia requiring medication or presenting with severe clinical symptoms; 4) Uncontrolled or symptomatic congestive heart failure (\> NYHA Class 2)

6\. Severe infectious diseases (untreated tuberculosis, pulmonary aspergillosis).

7\. Individuals deemed ineligible for enrollment by the investigator.

Where it's running

• Blood Diseases Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Hui Wei, MD
• Email: weihui@ihcams.ac.cn
• Phone: 13132507161

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.