Actively Recruiting
Standard-dose vs Intermediate-dose Cytarabine Induction in the Treatment of Acute Myeloid Leukemia With RUNX1-RUNX1T1
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-03-27
300
Participants Needed
1
Research Sites
255 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Leukemia is one of the common malignant tumors that threaten human health. Although the efficacy of AML treatment has improved significantly in recent years, it remains one of the major diseases threatening human health. Current research on AML treatment mainly has two directions. One is the addition of new targeted therapy drugs, and the other research direction is to enhance the intensity of AML chemotherapy, including the use of large doses of anthracycline drugs or the use of high-dose cytarabine treatment. Since the 1990s, induction remission has been achieved by using anthracyclines in combination with high-dose cytarabine. The ECOG (Eastern Cooperative Oncology Group) contends that high-dose induction chemotherapy fails to enhance the bone marrow remission rate but elevates the chemotherapy-related mortality rate. Bradstock and the Australian Group also noted that although it does not increase the bone marrow remission rate, it can result in longer survival time and disease-free survival time. The clinical study from EORTC-GIMEMA AML-12 discovered that AML patients under the age of 45 could benefit from induction therapy incorporating high-dose cytarabine. In our previous randomized controlled clinical trials, it was found that the HAD and DA regimens containing intermediate-dose cytarabine could enhance the complete remission rate and improve the overall survival of adult AML. However, the degree of benefit varies among different AML subgroups. The abnormalities of RUNX1-RUNX1T1 and CBFβ-MYH11 respectively involve a subunit of CBF (core binding factor), thus the two are collectively called CBF leukemia. Previous retrospective studies show that this type of leukemia benefits from intensified treatment regimens such as FLAG. However, at present, there is a lack of prospective randomized controlled clinical studies to confirm this. Therefore, in this study, we intend to further verify through a prospective randomized controlled clinical trial whether the induction treatment regimen containing intermediate-dose cytarabine can improve the long-term efficacy of adult RUNX1-RUNX1T1 acute myeloid leukemia.
CONDITIONS
Official Title
Standard-dose vs Intermediate-dose Cytarabine Induction in the Treatment of Acute Myeloid Leukemia With RUNX1-RUNX1T1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with AML according to WHO (2022) or ICC criteria
- Presence of RUNX1::RUNX1T1 fusion gene
- Age between 14 and 60 years, any gender
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Laboratory tests within 7 days before treatment showing: total bilirubin no more than 1.5 times upper normal limit; AST and ALT no more than 2.5 times upper normal limit; serum creatinine less than 2 times upper normal limit; cardiac enzymes less than 2 times upper normal limit; echocardiography ejection fraction above 50%
- Signed informed consent by patient or legal guardian if patient signature is not feasible
You will not qualify if you...
- Acute promyelocytic leukemia with PML-RARA fusion gene
- AML with BCR-ABL fusion gene
- Patients undergoing retreatment (except cytoreductive therapy allowed)
- Concurrent malignant tumors in other organs requiring treatment
- Active cardiac disorders including uncontrolled angina, recent myocardial infarction within 6 months, significant arrhythmia needing medication or severe symptoms, or congestive heart failure above NYHA Class 2
- Untreated severe infections such as tuberculosis or pulmonary aspergillosis
- Any condition deemed by the investigator to make the patient ineligible
AI-Screening
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Trial Site Locations
Total: 1 location
1
Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
H
Hui Wei, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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