RecruitingPhase 3NCT06744504

Standard-dose vs Intermediate-dose Cytarabine Induction in the Treatment of Acute Myeloid Leukemia With RUNX1-RUNX1T1

Anthracycline-based Standard-dose vs Intermediate-dose Cytarabine Induction in the Treatment of Acute Myeloid Leukemia With RUNX1-RUNX1T1: a Prospective, Randomized, Controlled Phase III Clinical Trial


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

300 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 14 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study compares two different doses of the chemotherapy drug cytarabine during the initial treatment (induction) of a specific type of acute myeloid leukemia (AML) that carries a gene fusion called RUNX1-RUNX1T1, to determine which dose leads to better outcomes. **You may be eligible if...** - You are between 14 and 60 years old - You have been newly diagnosed with AML that has the RUNX1::RUNX1T1 gene fusion - You are in reasonably good physical condition (ECOG 0–2) - Your liver, kidney, and heart function are within acceptable limits **You may NOT be eligible if...** - You have acute promyelocytic leukemia (a different subtype of AML) with a PML-RARA gene change - Your AML has a BCR-ABL gene change (more like CML) - You are undergoing retreatment for a relapse - You have another active cancer requiring treatment - You have significant heart disease (recent heart attack, uncontrolled heart failure, or severe arrhythmia) - You have severe uncontrolled infection (such as tuberculosis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGcytarabine

Cytarabine combined with daunorubicin was used for induction therapy. According to the different doses of cytarabine, it was divided into standard dose group and intermediate dose group.In addition, high doses of cytarabine are also used for post-remission treatment.

DRUGdaunorubicin

combined with cytarabine and used for induction therapy

DRUGidarubicin

combined with cytarabine and cyclophosphamide and used for post-remission treatment

DRUGcyclophosphamide

combined with cytarabine and idarubicin and used for post-remission treatment


Locations(1)

Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

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NCT06744504


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